13 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sterile Syringe With Safety Needle
FDA 510(k)
FDA Class 2
·General Hospital
BD Difco™ QC Antigen Salmonella O Group F
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902117537·BD Difco™ QC Antigen Salmonella O Group F
LuxaFlow®
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2117530·Flowable light cure provisional add-on material...
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4
FDA 510(k)
FDA Class 2
·Physical Medicine
HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 11, 2012
KARDIAMOBILE
FDA Adverse Event
Malfunction
·ALIVECOR·Product code DPS·January 24, 2022
TRABECULAR METAL MODULAR ACETABULAR SYSTEM SHELL WITH CLUSTER HOLES
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWB·October 24, 2008
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 10, 2011
M2A-MAGNUM 42-50MM TAPER INSERT-6
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 8, 2013
COBAS® DPX - 192T
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 17, 2025
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025