8 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PERFECTA TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Brigade
FDA UDI
Nuvasive, Inc.·00887517964465·Brigade Lateral Trial, 18x34x28mm 10°
DW 276 #3
FDA 510(k)
FDA Class 2
·Dental
MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UNIFY CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·June 30, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·October 26, 2007
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON. INC.·Product code FTL·January 9, 2013
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