11 results
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19ms
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Sources: EU EUDAMED, US FDA
27-210 PLASTER KNIFE (REINER)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Generic Buccal Tubes
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746162725·WELD TUBE INCONEL Ø 036 12" 2/PK
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209106189·
OSTEOVATION CMF BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Neurology
ActTrust
FDA 510(k)
FDA Class 2
·Neurology
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·April 11, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 30, 2012
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·September 29, 2010
GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015