7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)
FDA 510(k)
FDA Class 2
·Radiology
V8 TRANSLUMINAL BAV CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·January 29, 2013
WAVESCAN WAVEFRONT SYSTEM
FDA Adverse Event
Malfunction
·AMO MANUFACTURING USA, LLC·Product code HKO·November 24, 2010
AMK TIB INS SIZE 4 12MM
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