19 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GC AADVA ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00721001·
LEONE SPA
FDA UDI
LEONE SPA·08033707000808·PLATES LATERAL LEVELS HARD S/STEEL 0,5mm
STRYKER 2000
FDA UDI
Conmed Corporation·10845854006368·STRYKER 2000 SAGITTAL BLADE REPLACEMENT 24.94 X...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702382891·Elvarex 2/Mid Thigh High/Slant, Closed Toe, E-V...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702542752·Elvarex Forte 3/Knee High/Closed Toe-Elephantia...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702291186·Elvarex 3/Thigh High/Slant-Closed Toe-Elephanti...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702480597·ELVAREX 1/THIGH HIGH/SLANT-OPEN TOE/DOTTED SIL....
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702442274·Elvarex 4/Thigh High/Slant-Closed Toe/Dotted S...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702545821·EF3/AG/SL-OT-E/NOP2,5-T-TC/BL
XIMX SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010
FDA 510(k)
FDA Class 2
·Neurology
MetaSystems Probes
FDA UDI
MetaSystems Probes GmbH·04251315818941·XL t(14;16), Dual Fusion Probe
SM104 M-SERIES W/5TH WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·April 21, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
1076 AURICAL OTOCAM 300
FDA Adverse Event
Malfunction
·NATUS MEDICAL DENMARK·Product code ERA·June 29, 2021
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 27, 2025
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017