21 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MASTERSCREEN PAED - BABY BODY
FDA 510(k)
FDA Class 2
·Anesthesiology
ComfortGel
FDA UDI
Respironics, Inc.·00606959021044·ComfortGel Blue Full, Extra Large, China
EVOLIS 3031.0003 CEMENTLESS TIBIAL BASEPLATE SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 22, 2023
LINKMAX
FDA 510(k)
FDA Class 2
·Dental
BIOREHAB SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
WAVEWRITER ALPHA? PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 14, 2025
EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2011
EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 29, 2011
EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·January 14, 2011
EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·April 13, 2011
EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·September 9, 2011
EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 14, 2011
EVOLIS STD FEMUR TI PLASMA SPRAYED RIGHT SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 25, 2019
EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·February 21, 2014
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·April 29, 2013
DEPUY ASR HIP RESURFACING SYSTEM
FDA Adverse Event
Death
·DEPUY·Product code KWA·May 3, 2011
PUMP MMT-715LNAP PRDGM INS V2.1 PL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·July 23, 2008
BD¿ VENFLON IV CANNULA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·August 5, 2019
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015