7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aesculap Caiman 5 Seal and Cut Technology System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16
FDA 510(k)
FDA Class 2
·General Hospital
VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3
FDA 510(k)
FDA Class 2
·Radiology
PUMP MMT-508UC EA INSULIN CH EN US
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·October 15, 2008
CONCERTO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·July 2, 2013
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