17 results · 38ms · Sources: EU EUDAMED, US FDA

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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