11 results
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26ms
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Sources: EU EUDAMED, US FDA
WET-NO-MORE MONITOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
7.3mm BONE-LOK Implant
FDA UDI
INTERVENTIONAL SPINE, INC·81195401094248·7.3mm Diameter by 120-130mm (32) Length
NA
FDA UDI
STRYKER CORPORATION·07613327117035·Utility Brush
SHAPE TO FIT COMPRESSION WEAR
FDA 510(k)
FDA Class 2
·General Hospital
ELECSYS INSULIN CALSET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·May 7, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 17, 2010
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 21, 2012
ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC CRYOCATH LP·Product code OAE·May 14, 2020
UNKNOWN HIP FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KXA·September 19, 2019
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