20 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Fractional CO2 Laser Machine
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813035443·Reamers With Silicone Stops 21MM #25
Oticon
FDA UDI
Sbo Hearing A/S·05714464091768·OTICON JET 1 MINIRITE T C092
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154629565·Z-PLATE, SMALL, RIGHT
AbStats Gateway
FDA 510(k)
FDA Class 2
·Cardiovascular
Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite
FDA 510(k)
FDA Class 2
·Orthopedic
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 30, 2026
UNKNOWN DEPUY HIP LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWB·December 2, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 16, 2011
SCREWDRIVER HANDLE REVOLVING TYPE
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-FREIBURG·Product code LXH·July 29, 2013
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013