14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Zio AT® device (A100A1001)
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257129937·30-40 MV FOR MEN CLSC EW STD TAN VII
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257128411·30-40 MV FOR MEN SEL EW CLF STD TAN VII
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690117438·Modular Knee Stem Pilot 17mm x 75mm
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780455479·Integra® Jarit® Cobb Style Bone Curette, Hollow...
MEDOS HILITE OXYGENATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Low-frequency Multi-function physiotherapy instrument
FDA 510(k)
FDA Class 2
·Neurology
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 24, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
34MM X 4MM SAG MICRO BLADE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013
BD VERITOR ¿ SARS-COV-2 & FLU A+B
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QMN·January 25, 2024
BD VERITOR ¿ SARS-COV-2 & FLU A+B
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QMN·January 25, 2024
BD VERITOR ¿ SARS-COV-2 & FLU A+B
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QMN·April 10, 2024
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