9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BACT-HME (TM)
FDA 510(k)
FDA Class 1
·Anesthesiology
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828173346·GEN4 INTERACTIVE
GEN4 INTERACTIVE
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828184441·GEN4 INTERACTIVE
GEN4 INTERACTIVE
LASER 3 SPSC300
FDA 510(k)
FDA Class 2
·Physical Medicine
TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Death
·EV3 NEUROVASCULAR·Product code OUT·June 30, 2014
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·November 30, 2012
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code MTA·November 12, 2010
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