138 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169502413·SCREW 2150135 SCREW 35MM
CUI TEXTURED SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·August 7, 2024
RUSCH
FDA UDI
TELEFLEX INCORPORATED·14026704711823·Rusch Polaris FO Blade, Mac 3.5
RUSCH
FDA UDI
TELEFLEX INCORPORATED·14026704629708·Rusch Polaris FO Blade, Mac 3.5
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690117506·Distal Reamer (Hudson)
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690111627·Modular Stem 13mm x 150mm
TiLock
FDA UDI
Genesys Orthopedics Systems LLC·M719G1501350·Pre-Bent Rod
K-C HEMOSTATIC BIOPSY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GDS-DC12
FDA 510(k)
FDA Class 2
·Cardiovascular
MUSTANG
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·May 23, 2019
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWQ·November 10, 2017
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWQ·November 10, 2017
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 25, 2014
PULSAR-18 6/120/135
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code NIP·December 28, 2023
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 7, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
GREENLIGHT XPS MOXY FIBER OPTIC
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS·Product code GEX·May 30, 2013
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2016
MUSTANG¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·August 28, 2017