Chrysalis Intelligence · Sponsors · Jiangsu Shenli Medical Production Co., Ltd.

Jiangsu Shenli Medical Production Co., Ltd.

Changzhou City, CN · 1 510(k) clearances · 87 recalls

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Total clearances
1
2020-09-28 → 2020-09-28
Last 12 months
0
Product codes
1
Most recent
2020-09-28
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PNR Enteral Syringes With Enteral Specific Connectors Class II Gastroenterology, Urology 1 2020-09-28
Safety

Recalls (87)

Class I (serious)
0
Risk of injury / death
Total recalls
87
Currently ongoing
87
Most recent
2024-04-05
DateSeverityStatusRecall # ProductCodeReason
2024-04-05 Class II Ongoing Z-2128-2024 Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product Description: NON-Sterile syri… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2127-2024 Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Steri… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2126-2024 Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE HEP FLUSH Model/Catalog Number: 91862 Product Description: NON-Ste… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2125-2024 Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE CONTRAST Model/Catalog Number: 91860 Product Description: NON-Ster… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2124-2024 Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M Product Description: NON-Sterile sy… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2123-2024 Brand Name: GMAX Product Name: SYR 60ML/LL Blue syringe Model/Catalog Number: TS2260LB-M Product Description: NON-Ste… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2122-2024 Brand Name: GMAX Product Name: SYR 10ML/LL Blue syringe Model/Catalog Number: TS2210B-M Product Description: NON-Ster… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2121-2024 Brand Name: GMAX Product Name: SYR 10ML Control syringe Model/Catalog Number: TS3210L-M Product Description: NON-Ster… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2120-2024 Brand Name: GMAX Product Name: SYR 60ML/LS syringe Model/Catalog Number: TS2260S-M Product Description: NON-Sterile s… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2119-2024 Brand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS2220S-M Product Description: NON-Sterile s… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2118-2024 Brand Name: GMAX Product Name: SYR 12ML/LS syringe Model/Catalog Number: TS2212S-M Product Description: NON-Sterile s… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2117-2024 Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M Product Description: NON-Sterile s… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2116-2024 Brand Name: GMAX Product Name: SYR 60ML/LL syringe Model/Catalog Number: TS2260L-M Product Description: NON-Sterile s… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2115-2024 Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Description: NON-Sterile s… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2114-2024 Brand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-M Product Description: NON-Sterile s… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2113-2024 Brand Name: GMAX Product Name: SYR 20ML/LL syringe Model/Catalog Number: TS2220L-M Product Description: NON-Sterile s… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2112-2024 Brand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS2212L-M Product Description: NON-Sterile s… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2111-2024 Brand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS2210L-M Product Description: NON-Sterile s… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2110-2024 Brand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product Description: NON-Sterile sy… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2109-2024 Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M Product Description: NON-Sterile sy… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2108-2024 Brand Name: GMAX Product Name: SYR 3ML/LL syringe Model/Catalog Number: TS2203L-M Product Description: NON-Sterile sy… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2107-2024 Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2106-2024 Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2105-2024 Brand Name: Wolf Medical Product Name: 20 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2104-2024 Brand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2103-2024 Brand Name: Wolf Medical Product Name: 6 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR0… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2102-2024 Brand Name: Wolf Medical Product Name: 3 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR0… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2101-2024 Brand Name: Wolf Medical - WOLF-PAK Product Name: DISPOSABLE SYRINGE 1 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGEN… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2100-2024 Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number: 10025 Product Descr… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2099-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L CONTROL Model/Catalog Number: 91881 Product Description: NON-Sterile s… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2098-2024 Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L BLUE Model/Catalog Number: 91880 Product Description: NON-Steril… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2097-2024 Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L GREEN Model/Catalog Number: 91879 Product Description: NON-Steri… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2096-2024 Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L RED Model/Catalog Number: 91878 Product Description: NON-Sterile… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2095-2024 Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L YELLOW LIDO Model/Catalog Number: 91877 Product Description: NON… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2094-2024 Brand Name: MEDLINE Product Name: SYR CNTR 10ML L/L YELLOW Model/Catalog Number: 91876 Product Description: NON-Steri… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2093-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/S RED Model/Catalog Number: 91874 Product Description: NON-Sterile syrin… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2092-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/S WHITE LIDO Model/Catalog Number: 91873 Product Description: NON-Steril… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2091-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/S BLUE Model/Catalog Number: 91872 Product Description: NON-Sterile syri… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2090-2024 Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE HEPARIN Model/Catalog Number: 91867 Product Description: NON-Steri… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2089-2024 Brand Name: MEDLINE Product Name: SYR 5ML L/L RED NITRO Model/Catalog Number: 91866 Product Description: NON-Sterile … — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2088-2024 Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW LIDO Model/Catalog Number: 91863 Product Description: NON-Steri… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2087-2024 Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE NITRO Model/Catalog Number: 91859 Product Description: NON-Steri… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2086-2024 Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE SALINE Model/Catalog Number: 91858 Product Description: NON-Ster… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2085-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN CONT Model/Catalog Number: 91857 Product Description: NON-Steril… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2084-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L RED CONT Model/Catalog Number: 91856 Product Description: NON-Sterile … — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2083-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW HEP/SALINE Model/Catalog Number: 91855 Product Description: NON… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2082-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW LIDO Model/Catalog Number: 91854 Product Description: NON-Steri… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2081-2024 Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW NITRO Model/Catalog Number: 91852 Product Description: NON-Steri… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2080-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L RED HEPARIN Model/Catalog Number: 91851 Product Description: NON-Steri… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2079-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L RED LIDO Model/Catalog Number: 91850 Product Description: NON-Sterile … — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2078-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE SALINE Model/Catalog Number: 91849 Product Description: NON-Steri… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2077-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE LIDO Model/Catalog Number: 91847 Product Description: NON-Sterile… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2076-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW CONT Model/Catalog Number: 91846 Product Description: NON-Steri… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2075-2024 Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE SALINE Model/Catalog Number: 91845 Product Description: NON-Steri… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2074-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L PURPLE Model/Catalog Number: 91842 Product Description: NON-Sterile sy… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2073-2024 Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE Model/Catalog Number: 91841 Product Description: NON-Sterile syr… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2072-2024 Brand Name: MEDLINE Product Name: SYR 3ML L/L PURPLE Model/Catalog Number: 91840 Product Description: NON-Sterile syr… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2071-2024 Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW Model/Catalog Number: 91839 Product Description: NON-Sterile sy… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2070-2024 Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE Model/Catalog Number: 91838 Product Description: NON-Sterile syr… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2069-2024 Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE Model/Catalog Number: 91837 Product Description: NON-Sterile syri… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2068-2024 Brand Name: MEDLINE Product Name: SYR 20ML L/L GREEN Model/Catalog Number: 91836 Product Description: NON-Sterile syr… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2067-2024 Brand Name: MEDLINE Product Name: SYR 20ML L/L RED Model/Catalog Number: 91835 Product Description: NON-Sterile syrin… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2066-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW Model/Catalog Number: 91834 Product Description: NON-Sterile sy… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2065-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L WHITE Model/Catalog Number: 91833 Product Description: NON-Sterile syr… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2064-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE Model/Catalog Number: 91832 Product Description: NON-Sterile syri… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2063-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN Model/Catalog Number: 91831 Product Description: NON-Sterile syr… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2062-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L RED Model/Catalog Number: 91830 Product Description: NON-Sterile syrin… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2061-2024 Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW Model/Catalog Number: 91829 Product Description: NON-Sterile syr… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2060-2024 Brand Name: MEDLINE Product Name: SYR 5ML L/L WHITE Model/Catalog Number: 91828 Product Description: NON-Sterile syri… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2059-2024 Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE Model/Catalog Number: 91827 Product Description: NON-Sterile syrin… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2058-2024 Brand Name: MEDLINE Product Name: SYR 5ML L/L GREEN Model/Catalog Number: 91826 Product Description: NON-Sterile syri… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2057-2024 Brand Name: MEDLINE Product Name: SYR 5ML L/L RED Model/Catalog Number: 91825 Product Description: NON-Sterile syring… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2056-2024 Brand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91822 Product Description: NON-Sterile syrin… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2055-2024 Brand Name: MEDLINE Product Name: SYR 3ML L/L GREEN Model/Catalog Number: 91821 Product Description: NON-Sterile syri… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2054-2024 Brand Name: MEDLINE Product Name: SYR 3ML L/L RED Model/Catalog Number: 91820 Product Description: NON-Sterile syring… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2053-2024 Brand Name: MEDLINE Product Name: SYR 1ML TB Model/Catalog Number: 83089 Product Description: NON-Sterile syringes wi… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2052-2024 Brand Name: MEDLINE Product Name: SYR 20ML L/L Model/Catalog Number: 83088 Product Description: NON-Sterile syringes … — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2051-2024 Brand Name: MEDLINE Product Name: SYR 20ML L/S Model/Catalog Number: 83087 Product Description: NON-Sterile syringes … — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2050-2024 Brand Name: MEDLINE Product Name: SYR 5ML L/S Model/Catalog Number: 83085 Product Description: NON-Sterile syringes w… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2049-2024 Brand Name: MEDLINE Product Name: SYR 3ML L/L Model/Catalog Number: 83084 Product Description: NON-Sterile syringes w… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2048-2024 Brand Name: MEDLINE Product Name: SYR 3ML L/S Model/Catalog Number: 83083 Product Description: NON-Sterile syringes w… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2047-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L Model/Catalog Number: 83082 Product Description: NON-Sterile syringes … — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2046-2024 Brand Name: MEDLINE Product Name: SYR 10ML L/S Model/Catalog Number: 83081 Product Description: NON-Sterile syringes … — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2045-2024 Brand Name: MEDLINE Product Name: SYR 60ML L/L Model/Catalog Number: 83080 Product Description: NON-Sterile syringes … — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2044-2024 Brand Name: MEDLINE Product Name: SYR 60ML L/S Model/Catalog Number: 83079 Product Description: NON-Sterile syringes … — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2043-2024 Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes … — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
2024-04-05 Class II Ongoing Z-2042-2024 Brand Name: MEDLINE Product Name: SYR 30ML/LS Model/Catalog Number: 83077 Product Description: NON-Sterile syringes w… — Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2020-09-28 K200557 Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) PNR Class II Gastroenterology, Urology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence