10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
DEFIANCE MODEL FUS 336
FDA 510(k)
FDA Class 1
·Dental
PNEUMOTHERML, MODEL: 5800
FDA 510(k)
FDA Class 2
·Anesthesiology
CORDLESS COMPACT MOBILE X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
LOGIC TIBIA PS MOD INSRT SZ 5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 25, 2023
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 30, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 18, 2010
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013
IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code ERL·February 13, 2017
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·December 23, 2024
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