17 results
·
38ms
·
Sources: EU EUDAMED, US FDA
MG REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CoRoent
FDA UDI
Nuvasive, Inc.·00887517379924·CoRoent Contoured Trial, 5S
DD cubeX² ML
FDA UDI
Dental Direkt GmbH·EDDIG8520051·High translucent zirconia for the manufacture o...
LEONE SPA
FDA UDI
LEONE SPA·08033707030515·WEB 1ST MOL BANDS W/G8325-02 UR 5
Continuum® Trilogy® Allofit® Vivacit-E®
FDA UDI
Zimmer, Inc.·00889024364493·
MONTAGE Settable, Resorbable Hemostatic Bone Putty
FDA 510(k)
FDA Unclassified
·Unknown
R&R EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·July 24, 2020
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·May 13, 2021
ESSURE
FDA Adverse Event
Malfunction
·BAYER PHARMA AG·Product code HHS·October 15, 2018
POWERLINK SYSTEM
FDA Adverse Event
Injury
·ENDOLOGIX, INC.·Product code MIH·June 5, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 30, 2012
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FPO·September 24, 2010
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·July 20, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·February 26, 2018
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
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023