19 results
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24ms
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Sources: EU EUDAMED, US FDA
TP BIURET REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CoRoent
FDA UDI
Nuvasive, Inc.·00887517379931·CoRoent Contoured Trial, 6S
DD cubeX² ML
FDA UDI
Dental Direkt GmbH·EDDIG8520061·High translucent zirconia for the manufacture o...
LEONE SPA
FDA UDI
LEONE SPA·08033707030522·WEB 1ST MOL BANDS W/G8325-02 UR 6
Continuum® Trilogy® Allofit® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024155442·
Continuum® Trilogy® Allofit® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024364509·
POWDER-FREE VINYL EXAM GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
Cogent Hemodynamic Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·August 11, 2020
BRAVO
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code FFT·June 19, 2008
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·June 5, 2014
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 30, 2012
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·September 24, 2010
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 8, 2021
VICRYL POLYGLACTIN 910
FDA Adverse Event
ETHICON·Product code GAM·February 27, 2006
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·April 13, 2020
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·December 5, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·December 7, 2017
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
FDA Enforcement
Class II
·Ongoing·Osteomed, LLC·December 15, 2021