9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MESA SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DIOMED 15 DIODE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 3, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 12, 2011
GUARDIAN ROLLING WALKER
FDA Adverse Event
Malfunction
·A&E·Product code ITJ·May 22, 2008
OXYSURE
FDA Adverse Event
Injury
·OXYSURE·Product code CAW·March 19, 2014
OXYSURE
FDA Adverse Event
Injury
·OXYSURE·Product code DQA·March 19, 2014
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