9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POROCOAT FREEMAN/SAMUELSON TOTAL KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
URICHEMTRAK LIQUID ASSAYED URINE CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II
FDA 510(k)
FDA Class 2
·Microbiology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014
HS HAND CONTROLLED CURVED SHEA
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GEI·December 17, 2007
LCP PROXTIBPL 3.5 LAT R SHAFT 4HO L81 TI
FDA Adverse Event
Malfunction
·SYNTHES ELMIRA·Product code HRS·October 11, 2012
ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·August 14, 2019
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024