8 results
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17ms
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Sources: EU EUDAMED, US FDA
HEATED GUTTA PERCHA DELIVERY SYSTEM
FDA 510(k)
FDA Class 1
·Dental
LEADER
FDA UDI
Cardinal Health 110, Inc.·00096295142716·LDR Nitrile Exam Gloves Medium non-sterile Powd...
PORT CASSETTE
FDA 510(k)
FDA Class 2
·Radiology
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 27, 2014
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. HOMECARE PRODUCT, INC·Product code INI·November 14, 2012
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 13, 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