Chrysalis Intelligence · Sponsors · Teleflex Medical

Teleflex Medical

Morrisville, NC, US · 15 510(k) clearances · 11 PMAs · 26 recalls (7 Class I)

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Total clearances
15
2020-03-19 → 2026-07-09
Last 12 months
2
Product codes
11
Most recent
2026-07-09
Name variants in FDA filings: Teleflex Medical, LLC / Teleflex Medical
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FZP Clip, Implantable Class II General, Plastic Surgery 3 2025-07-03
GAT Suture, Nonabsorbable, Synthetic, Polyethylene Class II General, Plastic Surgery 2 2026-05-06
FMI Needle, Hypodermic, Single Lumen Class II General Hospital 2 2023-07-25
NEW — — — 1 2026-07-09
BTR — — — 1 2025-04-29
POD — — — 1 2025-03-18
DQX Wire, Guide, Catheter Class II Cardiovascular 1 2024-09-18
BTO Tube, Tracheostomy (W/Wo Connector) Class II Anesthesiology 1 2024-03-22
BSO Catheter, Conduction, Anesthetic Class II Anesthesiology 1 2023-08-30
EZC Catheter, Coude Class II Gastroenterology, Urology 1 2022-08-29
GAW Suture, Nonabsorbable, Synthetic, Polypropylene Class II General, Plastic Surgery 1 2020-03-19
Class III

PMA approvals (11)

Total PMA records
11
Originals + supplements
Distinct product codes
1
First decision
2020-01-23
Most recent
2026-04-23
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-04-23 P180025-S016 MANTA™ Vascular Closure Device 30-Day Notice MGB — —
2026-02-27 P180025-S015 MANTA™ Vascular Closure Device 30-Day Notice MGB — —
2025-08-05 P180025-S014 MANTA™ Vascular Closure Device; MANTA Vascular Closure Device, 18F; MANTA Vascular Closure Device, 14F; MANTA SF Depth L 30-Day Notice MGB — —
2025-01-03 P180025-S013 MANTA™ Vascular Closure Device 30-Day Notice MGB — —
2024-06-07 P180025-S012 MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator Normal 180 Day Track No User Fee MGB — —
2024-03-06 P180025-S011 MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator 30-Day Notice MGB — —
2023-10-11 P180025-S010 MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator Normal 180 Day Track No User Fee MGB — —
2021-04-19 P180025-S009 MANTA Vascular Closure Device Normal 180 Day Track MGB — —
2020-09-18 P180025-S008 MANTA Vascular Closure Device 30-Day Notice MGB — —
2020-05-26 P180025-S007 MANTA Vascular Closure Device 30-Day Notice MGB — —
2020-01-23 P180025-S006 MANTA Vascular Closure Device Real-Time Process MGB — —
Safety

Recalls (26)

Class I (serious)
7
Risk of injury / death
Total recalls
26
Currently ongoing
6
Most recent
2022-04-11
DateSeverityStatusRecall # ProductCodeReason
2022-04-11 Class II Ongoing Z-1127-2022 (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, steri… — Reports received of torn corrugated breathing tubes.
2022-04-11 Class II Ongoing Z-1126-2022 (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-steril… — Reports received of torn corrugated breathing tubes.
2022-01-11 Class I Terminated Z-0629-2022 Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Per… — The firm received reports indicating PTD tip separation during use.
2022-01-11 Class I Terminated Z-0628-2022 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-030… — The firm received reports indicating PTD tip separation during use.
2022-01-11 Class I Terminated Z-0627-2022 Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T … — The firm received reports indicating PTD tip separation during use.
2022-01-11 Class I Terminated Z-0626-2022 Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-657… — The firm received reports indicating PTD tip separation during use.
2022-01-11 Class I Terminated Z-0625-2022 Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C… — The firm received reports indicating PTD tip separation during use.
2022-01-11 Class I Terminated Z-0624-2022 Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65… — The firm received reports indicating PTD tip separation during use.
2022-01-11 Class I Terminated Z-0623-2022 Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-127… — The firm received reports indicating PTD tip separation during use.
2021-02-18 Class II Ongoing Z-1294-2021 RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is u… — Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hin…
2021-02-12 Class II Ongoing Z-1298-2021 PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use devi… — Teleflex is recalling this product due to a lack of assurance of sterility.
2020-08-07 Class II Terminated Z-2922-2020 Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical pro… — Potential sterility issue
2020-07-06 Class II Terminated Z-2732-2020 Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The laryngoscope is a device inten… — Breaking at the point of a welded joint
2020-07-06 Class II Terminated Z-2731-2020 Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The laryngoscope is a device int… — Breaking at the point of a welded joint
2020-07-06 Class II Terminated Z-2730-2020 Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The laryngoscope is a device int… — Breaking at the point of a welded joint
2020-07-06 Class II Terminated Z-2729-2020 Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Product Usage: The laryngoscope is a device int… — Breaking at the point of a welded joint
2020-07-06 Class II Terminated Z-2728-2020 Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The laryngoscope is a device int… — Breaking at the point of a welded joint
2020-07-06 Class II Terminated Z-2727-2020 Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage: The laryngoscope is a device in… — Breaking at the point of a welded joint
2020-07-06 Class II Terminated Z-2726-2020 Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device int… — Breaking at the point of a welded joint
2020-06-30 Class II Ongoing Z-2749-2020 Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/… — Potential for sterile packaging to be compromised¿
2020-06-30 Class II Ongoing Z-2748-2020 Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To evacuate air and/or flu… — Potential for sterile packaging to be compromised¿
2020-05-29 Class II Terminated Z-2533-2020 RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 1… — Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicating that the laser guard foil partially separated and/or slight…
2020-01-13 Class II Terminated Z-1270-2020 Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36K c) 4.0 … — There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
2020-01-13 Class II Terminated Z-1269-2020 Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440 — There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
2020-01-09 Class II Terminated Z-1117-2020 Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System — The products are being recalled due to reports of breakage broke at the point of a welded joint either prior to use during setup or during use inside the patien…
2020-01-09 Class II Terminated Z-1116-2020 Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System — The products are being recalled due to reports of breakage broke at the point of a welded joint either prior to use during setup or during use inside the patien…
Filings

All 510(k) clearances (15)

Date K-number Device Code Class Specialty
2026-07-09 K261988 Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture NEW — —
2026-05-06 K260775 Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ GAT Class II General, Plastic Surgery
2025-07-03 K251054 Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips FZP Class II General, Plastic Surgery
2025-04-29 K242495 LMA Fastrach ETT SU BTR — —
2025-03-18 K243553 QuikClot Control+ Hemostatic Device POD — —
2024-09-18 K241784 Arrow® Nitinol Wire DQX Class II Cardiovascular
2024-03-22 K233713 Pilling Tracheostomy Tubes BTO Class II Anesthesiology
2024-01-12 K232970 Hem-o-lok® Ligating Clips FZP Class II General, Plastic Surgery
2023-08-30 K230603 Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002) BSO Class II Anesthesiology
2023-07-25 K231924 EZ-IO Intraosseous Vascular Access System FMI Class II General Hospital
2023-04-28 K230480 Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) FZP Class II General, Plastic Surgery
2022-08-29 K222279 Rusch Intermittent Urethral Catheters EZC Class II Gastroenterology, Urology
2021-03-22 K202492 EZ-IO Intraosseous Vascular Access System FMI Class II General Hospital
2020-03-30 K192490 Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch GAT Class II General, Plastic Surgery
2020-03-19 K193530 Deklene MAXX GAW Class II General, Plastic Surgery
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence