15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REXLON, REXSIL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AQUILION LB MOVEMENT BASE KIT
FDA 510(k)
FDA Class 2
·Radiology
NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 11, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2014
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·May 6, 2021
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 7, 2025
KIT RSV 30 TEST HOSPITAL VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 15, 2021
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE S
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2020
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2020
LZOVERSAFITCUP CC TRIO NO HOLE CUP
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 3, 2019
MPACT ACETABULAR SHELL Ø52 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·August 29, 2018
BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·April 11, 2019
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018