11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRIDENT ELEVATED RIM LINER
FDA 510(k)
FDA Class 2
·Orthopedic
APC™ II Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221062154·Mini Uni-Twin(TM) Bracket APC(TM) II Standard E...
APC™ PLUS Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221093172·Mini Uni-Twin(TM) Bracket APC(TM) PLUS Standard...
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717106712·Paper Points, Taper .02, Size #25, 200pcs/box
3M™ Unitek™ Uni-Twin™
FDA UDI
3M UNITEK CORPORATION·00652221016249·Mini Uni-Twin(TM) Bracket Standard Edgewise UL4...
MODEL 4810 ANALYZER OUTPUT ADAPTER
FDA 510(k)
FDA Class 2
·Cardiovascular
VOYAGER/VIPER WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 26, 2013
TRAUMA TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·February 16, 2011
KENTROX RV 65
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code LWS·March 28, 2008
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012