Chrysalis Intelligence · Sponsors · Exact Medical Manufacturing

Exact Medical Manufacturing

Changzhou Jiangsu, CN · 2 510(k) clearances · 18 recalls

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Total clearances
2
2021-08-13 → 2023-05-12
Last 12 months
0
Product codes
1
Most recent
2023-05-12
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
ITX — — — 2 2023-05-12
Safety

Recalls (18)

Class I (serious)
0
Risk of injury / death
Total recalls
18
Currently ongoing
0
Most recent
2021-04-29
DateSeverityStatusRecall # ProductCodeReason
2021-04-29 Class II Terminated Z-1924-2021 Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664 — No 510k for the product to be used in a natural or surgical opening to the body
2021-04-29 Class II Terminated Z-1923-2021 Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576 — No 510k for the product to be used in a natural or surgical opening to the body
2021-04-29 Class II Terminated Z-1922-2021 Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29 — No 510k for the product to be used in a natural or surgical opening to the body
2021-04-29 Class II Terminated Z-1921-2021 Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22 — No 510k for the product to be used in a natural or surgical opening to the body
2021-04-29 Class II Terminated Z-1920-2021 Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17 — No 510k for the product to be used in a natural or surgical opening to the body
2021-04-29 Class II Terminated Z-1919-2021 Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL — No 510k for the product to be used in a natural or surgical opening to the body
2021-04-29 Class II Terminated Z-1918-2021 Hays Ultrasound kit Item ID: H1000SE — No 510k for the product to be used in a natural or surgical opening to the body
2021-04-29 Class II Terminated Z-1917-2021 Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N — No 510k for the product to be used in a natural or surgical opening to the body
2021-04-29 Class II Terminated Z-1916-2021 Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360 — No 510k for the product to be used in a natural or surgical opening to the body
2021-04-29 Class II Terminated Z-1915-2021 Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359 — No 510k for the product to be used in a natural or surgical opening to the body
2021-04-29 Class II Terminated Z-1914-2021 Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N — No 510k for the product to be used in a natural or surgical opening to the body
2021-04-29 Class II Terminated Z-1913-2021 Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N — No 510k for the product to be used in a natural or surgical opening to the body
2021-04-29 Class II Terminated Z-1912-2021 6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N — No 510k for the product to be used in a natural or surgical opening to the body
2021-04-29 Class II Terminated Z-1911-2021 Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N — No 510k for the product to be used in a natural or surgical opening to the body
2021-04-29 Class II Terminated Z-1910-2021 6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA — No 510k for the product to be used in a natural or surgical opening to the body
2021-04-29 Class II Terminated Z-1909-2021 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA — No 510k for the product to be used in a natural or surgical opening to the body
2021-04-29 Class II Terminated Z-1908-2021 Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA — No 510k for the product to be used in a natural or surgical opening to the body
2021-04-29 Class II Terminated Z-1907-2021 Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA — No 510k for the product to be used in a natural or surgical opening to the body
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2023-05-12 K222460 Intraoperative Ultrasound Probe Cover ITX — —
2021-08-13 K211969 EMM Ultrasonic Transducer Cover ITX — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence