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