8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RECON 1
FDA 510(k)
FDA Class 1
·Anesthesiology
PROTECTIV ACUVANCE IV CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
IMMUNODIFFUSSION REAGENTS/SEROLOGICAL
FDA 510(k)
FDA Class 2
·Microbiology
UNKNOWN ANATOMIC SHOULDER METAL COMPONENT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·May 26, 2026
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code KDJ·May 15, 2014
REVEAL XT
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DSI·October 31, 2012
INTERSTIM
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·August 17, 2010
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024