26 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
POUR-PLUS
FDA UDI
Denplus Inc·D8451151100·POUR-PLUS, CLR, 454 g
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704282931·LANGENBECK RETRACTOR 3/8"x1 1/4"
DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169524682·INSERTER 2151100 HANDLE INSERTER
AOS CLAMP 5.0mm PIN x 9.5mm ROD
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665005370·
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167521511000·
Precontoured Rod Ø5.5 mm x100 mm Package
FDA UDI
XENCO MEDICAL LLC·B064XM21511001·SETX Ø5.5mm x 100mm Precontoured Rod
Mini-Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFORN74101511001·Mini-Mono-Bracket Roth 'N' .022" max. 1 right
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702451078·E2/AG/SL-OT/OH-WOV/BLU
Mini-Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFORO74001511001·Mini-Mono-Bracket Roth 'N' .022" max. 1 left
Ø5.5mm X 100mm PRECONTOURED RODS
FDA UDI
XENCO MEDICAL LLC·B064XMPH21511002·
CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q
FDA 510(k)
FDA Class 2
·General Hospital
MetaSystems Probes
FDA UDI
MetaSystems Probes GmbH·04251315817524·XL EPOR BA, Break Apart Probe
SURESTEP
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CGA·April 14, 2000
EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code NKB·October 8, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013
ASR ACETABULAR IMPLANT 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 30, 2011
DIVERGENCE-L¿ ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MAX·October 19, 2021