17 results
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23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MOSS 100 Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
HairCheck-DT (Cocaine)
FDA UDI
Quest Diagnostics·00868586000216·HairCheck-DT (Cocaine) is an ELISA test kit use...
Bernafon
FDA UDI
Bernafon AG·05711584058800·SU7 P, VC PS MSIL/MAC SUITE 7
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
GMK NARROW
FDA 510(k)
FDA Class 2
·Orthopedic
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 9, 2017
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 16, 2019
COATED VICRYL
FDA Adverse Event
Malfunction
·ETHICON, INC·Product code GAM·July 8, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 11, 2013
TRILLIUM AFFINITY NT HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·MEDTRONIC PERFUSION SYSTEMS·Product code DTZ·September 3, 2008
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 17 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 26, 2021
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 15, 2022
GMK-PRIMARY TIBIAL INSERT UC FIXED 3 / 17 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 27, 2016
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 LEFT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 30, 2016
GMK PS TIBIAL INSERT SIZE 3 / 17 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·June 11, 2015
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