16 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517379986·CoRoent Contoured Trial, 4M
DD cubeX² ML
FDA UDI
Dental Direkt GmbH·EDDIG8520141·High translucent zirconia for the manufacture o...
LEONE SPA
FDA UDI
LEONE SPA·08033707030607·WEB 1ST MOL BANDS W/G8325-02 UR 14
Continuum® Trilogy® Allofit® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024155626·
Continuum® Trilogy® Allofit® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024155633·
Continuum® Trilogy® Allofit® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024155640·
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
FDA 510(k)
FDA Class 2
·Microbiology
MTS300 Multiple Tray Sterilization System
FDA 510(k)
FDA Class 2
·General Hospital
CONTOUR CURVED CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 5, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 30, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·September 24, 2010
LUCAS(R) 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Injury
·JOLIFE AB·Product code DRM·January 9, 2017
LUCAS(R) 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Injury
·JOLIFE AB·Product code DRM·January 5, 2017
LUCAS 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB·Product code DRM·January 9, 2018
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