9 results
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25ms
·
Sources: EU EUDAMED, US FDA
WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JOBST Relief
FDA UDI
BSN MEDICAL, INC.·04042809699913·RELIEF 20-30 MM HG KNEE HIGH DOT BAND OPEN TOE ...
KATALAVOX VOICE-ACTIVATED SWITCHING DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
ENTERAL NUTRITION PUMPS PN 1000 AND VM 05
FDA 510(k)
FDA Class 2
·General Hospital
TRIATHLON PS X3 TIBIAL INSERT
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·October 5, 2010
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·December 10, 2012
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2014
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
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015