16 results
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27ms
·
Sources: EU EUDAMED, US FDA
T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CoRoent
FDA UDI
Nuvasive, Inc.·00887517379955·CoRoent Contoured Trial, 8S
DD cubeX² ML
FDA UDI
Dental Direkt GmbH·EDDIG8520081·High translucent zirconia for the manufacture o...
LEONE SPA
FDA UDI
LEONE SPA·08033707030546·WEB 1ST MOL BANDS W/G8325-02 UR 8
Continuum® Trilogy® Allofit® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024155466·
Continuum® Trilogy® Allofit® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024155473·
Physica PS Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7
FDA 510(k)
FDA Class 2
·Physical Medicine
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·February 24, 2020
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·June 5, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 4, 2010
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 30, 2012
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·May 23, 2018
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·August 28, 2024
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
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015