8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021
PodSKAN HF Diagnostic X-ray System
FDA 510(k)
FDA Class 2
·Radiology
SYNTHES (USA) NEW/STERIAL ORBITAL PLATES
FDA 510(k)
FDA Class 2
·Dental
VERSACARED BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 15, 2014
LEVEEN NEEDLE ELECTRODE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code GEI·December 17, 2010
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·January 28, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024