7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EBNA IGG ELISA TEST SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
SILVER FOAM WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
M-VU BREAST DENSITY
FDA 510(k)
FDA Class 2
·Radiology
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 29, 2013
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 20, 2010
SYNATOMIC VF TIB CLIP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 14, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024