9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Male Latex Condoms
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD Difco™ Salmonella O Antiserum Group G1 Factors 13, 22, (36)
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902226116·BD Difco™ Salmonella O Antiserum Group G1 Facto...
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113782·PS-C Insert, Size 6 x 11mm
Catalyst OrthoScience R1 Reverse Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
COOLRAIL LINEAR PEN MODEL MCRI
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 25, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code ITI·November 4, 2014
FLEXCATH STEERABLE SHEATH
FDA Adverse Event
Malfunction
·MEDTRONIC CRYOCATH LP·Product code DRA·July 12, 2013
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024