9 results
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17ms
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Sources: EU EUDAMED, US FDA
THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
FDA 510(k)
FDA Class 1
·Microbiology
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984153·anteriors; shade A3.5; mould R 75
P.F.C.
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295252436·P.F.C. TIBIAL INSERT FIXED BEARING CURVED 4 10m...
OTT INSUFFLATOR FILTER PLUS/TUBING SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·February 10, 2011
FREESTYLE LITE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·September 28, 2016
MINIMAL ACCESS ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·December 18, 2013
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024