9 results
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17ms
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Sources: EU EUDAMED, US FDA
IMTEC BONE COLLECTOR SYSTEM
FDA 510(k)
FDA Class 1
·Dental
PRESTIGE® LP Cervical Disc System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994490421·TRIAL 6973248 IMPLANT
Stainless Steel Femoral Nailing System
FDA UDI
ORTHOFIX SRL·18032568862522·STERILE CANN. FEMORAL NAIL DIAMETER 12 MM LENG...
CARDIOSKIN
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·February 21, 2013
CE INFUSOR, LV 5 ML/H,12 PACK
FDA Adverse Event
Malfunction
·Product code MEB·January 28, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·August 1, 2014
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024