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