8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DESARA MESH, DESARA BLUE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NexxZr™ T / D-100-14-NT-B200-SD
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271112798·
WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
JOURNEY UNICONDYLAR TIBIAL BASEPLATES
FDA 510(k)
FDA Class 2
·Orthopedic
2124215-2014-14597
FDA Adverse Event
Malfunction
·GUIDANT PUERTO RICO BV·Product code LWS·October 1, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024