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Hayden Medical

Hayden Medical, Inc. · Model 365-200 · UDI-DI 00840319750537

GDJ Prescription
10
510(k) clearances
303
Adverse events (3 deaths)
9
Recalls
270
Facilities

Description

Hulka-Kenwick Uterine Elevating Forceps 10-3/4" (26.9cm), with double tooth & sound

Recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2024-05-16Medtronic Perfusion SystemsIncorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
2024-03-19Medtronic Perfusion SystemsPotential for unsealed sterile packing.
2018-06-29Integra LifeSciences Corp.There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
2018-06-29Integra LifeSciences Corp.There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
2018-06-29Integra LifeSciences Corp.There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
2018-06-29Integra LifeSciences Corp.There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
2013-07-02Stryker Howmedica Osteonics Corp.Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.
2005-04-06Smith & Nephew, Inc., Endoscopy Div.Cupped Grasper Handle marked incorrectly as Duckbill Upbiter

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.