13 results · 21ms · Sources: EU EUDAMED, US FDA

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CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Ophthalmic Retractor

FDA UDI
KATENA PRODUCTS, INC.·00841668101094·HELVESTON "BIG BARBIE" RETRACTOR 9MM

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319741450·House Alligator Ear Forceps 2-7/8" (7.3cm) shaf...

POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE).

FDA 510(k)
FDA Class 1 ·General Hospital

BIOLOX DELTA CERAMIC FEMORAL HEADS

FDA 510(k)
FDA Class 2 ·Orthopedic

PROMUS PREMIER?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·October 21, 2014

PONTO IMPLANT WITH ABUTMENT

FDA Adverse Event
Other ·OTICON MEDICAL AB·Product code LXB·June 13, 2013

X3 TRIATHLON CS INSERT #3 11MM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·July 28, 2011

UNKNOWN SALINE IMPLANTS

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·February 14, 2020

KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway

FDA Enforcement
Class II ·Terminated·King Systems Corp.·November 28, 2012

VIDAS® BRAHMS PROCALCITONIN

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code NTM·February 7, 2019

RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

FDA Enforcement
Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024