9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VOLUMAX CT IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091982060·posteriors; shade B3; size M; upper jaw
KING Snap Lead/DIN Connector
FDA UDI
Kego Corporation·00663427000079·KING Snap Lead/DIN Connector Qty 5
5 Color Red...
CRANIAL IMAGE GUIDED SURGERY SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MULTIFORMAT FILM CASSETTE TRANSPORT
FDA 510(k)
FDA Class 2
·Radiology
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS INC.·Product code LZG·February 8, 2013
12MM 0 DEGREE ENDOSCOPE
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·August 5, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 8, 2011
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024