17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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V-VITFREEZE and V-VITWARM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257128183·30-40 MV FOR MEN SEL EW CLF STD TAN VI
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257129920·30-40 MV FOR MEN CLSC EW STD TAN VI
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776383756·Cobb Curette, 11", straight, size 00
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780183983·Integra® Jarit® Cobb Style Bone Curette, 11", H...
FREEDOM Integrated Syringe Infusion System
FDA 510(k)
FDA Class 2
·General Hospital
MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 27, 2017
UTREX PLUS PENILE IMPLANTS
FDA Adverse Event
AMERICAN MEDICAL SYSTEMS·Product code FAE·February 7, 1994
ALARIS® PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·October 24, 2017
ALARIS® PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·October 17, 2017
ALARIS® PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·October 24, 2017
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·September 9, 2011
18.5MM X 10MM OSC. MICRO BLADE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013
Philips Azurion system; Software Version Number: R3.1;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 28, 2026
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025