13 results · 27ms · Sources: EU EUDAMED, US FDA

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PATHROMTIN

FDA 510(k)
FDA Class 2 ·Hematology

LP Low Profile

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746088889·DB BKT LP LR CUSP 018 T-6 A+3 R=0

Obtura Spartan

FDA UDI
Young Innovations, Inc.·00843471100875·EMS Threaded Tip KiS-1E

Obtura Spartan

FDA UDI
OBTURA SPARTAN ENDODONTICS·00816168020428·EMS Threaded Tip KiS-1E

LINK Endo-Model EVO Knee System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575267781·Femoral component, TiNbN coating, cemented, CoC...

GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE

FDA 510(k)
FDA Class 1 ·General Hospital

APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET

FDA 510(k)
FDA Class 2 ·General Hospital

SCREW,FIXATION,BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·May 18, 2015

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code IOR·January 28, 2013

UNKNOWN ZIMMER FEMORAL COMPONENT

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code JWH·November 30, 2010

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 14, 2014

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·July 27, 2015

OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021