2,946 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1
FDA 510(k)
FDA Class 2
·Cardiovascular
ECHO BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304463035·
Bernafon
FDA UDI
Bernafon AG·05711584086933·ZR3, KIT 312 NFM L BE ZERENA 3
Echo® Bi-Metric® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868260506·
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668101100·HELVESTON "GREAT BIG BARBIE" RETRACTOR 11MM
CONAIR
FDA Adverse Event
Malfunction
·CONAIR CORPORATION·Product code IRT·September 26, 2019
RESTORATION ACETABULAR WEDGE AUGMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
MODEL 1014 PC ELECTROMETER
FDA 510(k)
FDA Class 2
·Radiology
UNKNOWN DEPUY LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWB·October 6, 2008
OT ULTRALINK METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·August 4, 2011
MONARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·June 20, 2013
HEARTSTART HOME
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code NSA·November 21, 2019
ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
FDA Adverse Event
Malfunction
·ZYNO MEDICAL, LLC·Product code FRN·September 14, 2019
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 11, 2019
NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·June 18, 2019
COCHLEAR IMPLANT MODEL CI512 WITH CONTOUR ADVANCE ELECTRODE
FDA Adverse Event
Malfunction
·COCHLEAR LTD·Product code MCM·June 19, 2019
CADD SOLIS VIP PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·October 17, 2019
50CM IMPLANT LEAD KIT, SLIM TIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code PMP·May 2, 2019
BIA400 IMPLANT 4MM W ABUTMENT 8MM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·November 18, 2019
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC·Product code MNT·August 19, 2019