9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WATCHPAT100
FDA Adverse Event
Injury
·ITAMAR MEDICAL LTD.·Product code MNR·November 12, 2007
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 8, 2013
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
Injury
·CHAMPION MANUFACTURING·Product code KMN·March 29, 2011
CONTAK RENEWAL 3
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·September 22, 2016
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