11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12
FDA 510(k)
FDA Class 2
·Cardiovascular
DELTA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327373554·S-Drill Tap, Hex 43mm, 2.2 X 4mm Screw
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122819·K-WIRE - DOUBLE TROCAR 0.6mm DIA x 100mm
COPPERHEAD CERVICAL INTERBODY CAGE
FDA Adverse Event
Injury
·EMINENT SPINE·Product code ODP·January 8, 2016
THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL
FDA 510(k)
FDA Class 1
·General Hospital
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 3, 2013
CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·May 18, 2011
PUMP MMT-715NAB PRDGM INS V2.1 BL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·July 31, 2008
INNOVA 3100-IQ
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS SCS·Product code OWB·May 30, 2017
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