7 results
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26ms
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Sources: EU EUDAMED, US FDA
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)
FDA 510(k)
FDA Class 1
·Microbiology
MediBot Needle Driver Uno
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILTER PROBE ADAPTER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON MANUFACTURING, LTD.·Product code HQC·June 24, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 14, 2013
19MM MOD REV HIP BDY/BLT +10MMCOMPONENT LEVEL 9006
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS CORK·Product code LZO·December 21, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024