9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BACT/ALERT (TM)
FDA 510(k)
FDA Class 1
·Microbiology
Brigade
FDA UDI
Nuvasive, Inc.·00887517963161·Brigade Lateral Trial, 12x38x28mm 10°
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515229457·Elevator Knife
KFA-127 KNEE, FOOT AND ANKLE ARRAY
FDA 510(k)
FDA Class 2
·Radiology
ALTUM ANTERIOR CERVICAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 30, 2014
AIR DERMATOME HANDPIECE
FDA Adverse Event
Injury
·ZIMMER SURGICAL·Product code GFD·January 3, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·November 16, 2010
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