8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
INTELECT 170
FDA 510(k)
FDA Class 2
·Physical Medicine
LASEMAR 800, 1000, 1500
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODEL 6900GE-64: C-SPINE ARRAY
FDA 510(k)
FDA Class 2
·Radiology
BASE UNIT SERVO-U
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·October 26, 2023
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
TX1 TISSUE REMOVAL SYSTEM - CONSOLE
FDA Adverse Event
Malfunction
·TENEX HEALTH·Product code LFL·February 24, 2014
REPAIR CORE SAG SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·November 12, 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