15 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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KRD1 PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198727·AK3 Ultra Insert Trial Size 4, 20mm
HITACHI ALTAIRE
FDA 510(k)
FDA Class 2
·Radiology
MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01
FDA 510(k)
FDA Class 2
·Neurology
SOL-MILLENNIUM
FDA Adverse Event
Malfunction
·SOL-MILLENNIUM MEDICAL INC·Product code FMF·May 16, 2025
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180508015·PLIF/TLIF, Bayonetted, 7 MM Stirrup Scraper, Ri...
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180508022·PLIF/TLIF, Bayonetted, 7 MM Stirrup Scraper, Le...
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180508428·PLIF/TLIF, Bayonetted, 7 MM Stirrup Scraper, Do...
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180508008·PLIF/TLIF, Bayonetted, 7 MM Stirrup Scraper, St...
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180508039·PLIF/TLIF, Bayonetted, 7 MM Stirrup Scraper, Cr...
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180508411·PLIF/TLIF, Bayonetted, 7 MM Stirrup Scraper, Do...
FREESTYLE LITE
FDA Adverse Event
Injury
·Product code NBW·May 3, 2013
X SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·September 5, 2014
SYBRONPRO TL
FDA Adverse Event
Injury
·EBI INC.·Product code DZE·May 18, 2011
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