9 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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OVERSTITCH ENDOSCOPIC SUTURE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ComfortGel Blue
FDA UDI
Respironics, Inc.·00606959043947·ComfortGel Blue Full Mask with Standard Elbow, ...
SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1
FDA 510(k)
FDA Class 2
·General Hospital
ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ZYDERM 2 COLLEGEN IMPLANT (VOLUME UNSPECIFIED)
FDA Adverse Event
Other
·INAMED CORPORATION (FREMONT)·Product code LMH·July 28, 2005
VERTEBRAL SPACER-PR 8MMX22MM 7MM HEIGHT
FDA Adverse Event
Malfunction
·SYNTHES (USA·Product code MQP·April 29, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 9, 2011
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·July 22, 2008
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