10 results
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26ms
·
Sources: EU EUDAMED, US FDA
GASTRO-INTESTINAL ACCU-CULSHURE TM
FDA 510(k)
FDA Class 1
·Microbiology
Brigade
FDA UDI
Nuvasive, Inc.·00887517964496·Brigade Lateral Trial, 17x34x28mm 12°
AT-Patch ECG Analysis System
FDA 510(k)
FDA Class 2
·Cardiovascular
MOJAVE CATARACT EXTRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
ATLAS PLUS VR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 30, 2014
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·January 3, 2013
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·October 26, 2007
S-ROM M HEAD 36MM +9
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 14, 2011
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 14, 2011
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