10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Biomet Microfixation OmniMax MMF System
FDA 510(k)
FDA Class 2
·Dental
E.M Adams co, inc.
FDA UDI
E.M. ADAMS, INC.·10840200301609·SINGLE INSTRUMENT
E.M Adams co, inc.
FDA UDI
E.M. ADAMS, INC.·18100013401609·SINGLE INSTRUMENT
MPS450 MULTIPARAMETER SIMULATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
OPTISTRAND, MODEL 1032S
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 6, 2025
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC. CRMD·Product code DTB·January 13, 2014
5.0MM CANNULATED LOCKING SCREW80MM
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·June 3, 2013
50MM LFT STANDARD MAND
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·June 29, 2011
BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·October 17, 2018