12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EDEN Spinal Fixation MIS System
FDA 510(k)
FDA Class 2
·Orthopedic
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295507277·DELTA XTEND Lateralized Glenosphere +2mm Trial ...
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295507192·DELTA XTEND Lateralized Glenosphere +2mm Trial ...
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295507246·DELTA XTEND Lateralized Glenosphere +2mm Trial ...
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295507314·DELTA XTEND Lateralized Glenosphere +2mm Trial ...
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CoLink Cfx Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
1550 HEMODIALYSIS MACHINE
FDA Adverse Event
Injury
·LARGO·Product code KDI·November 17, 2008
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019