15 results · 26ms · Sources: EU EUDAMED, US FDA

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NEGATIVE CONTROL SERUM FOR CF RO ID

FDA 510(k)
FDA Class 2 ·Microbiology

BRILLIANT COMPONEER

FDA 510(k)
FDA Class 2 ·Dental

APPROACH HYDRO ST WIRE GUIDE, MODEL HMW

FDA 510(k)
FDA Class 2 ·Cardiovascular

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·May 5, 2014

PROTECTA XT CRT-D

FDA Adverse Event
Injury ·MEDTRONIC S.A.·Product code NIK·October 15, 2012

HAKIM VALVE

FDA Adverse Event
Malfunction ·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code JXG·May 22, 2015

VIDAS® ANALYZER

FDA Adverse Event
Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

VIDAS® ANALYZER

FDA Adverse Event
Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

VIDAS® ANALYZER

FDA Adverse Event
Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

VIDAS® ANALYZER

FDA Adverse Event
Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

VIDAS® ANALYZER

FDA Adverse Event
Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

VIDAS® ANALYZER

FDA Adverse Event
Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

VIDAS® ANALYZER

FDA Adverse Event
Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.

FDA Enforcement
Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 23, 2014

VIDAS® ANALYZER

FDA Adverse Event
Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·June 3, 2021