10 results · 36ms · Sources: EU EUDAMED, US FDA

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BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1

FDA 510(k)
FDA Class 2 ·Neurology

TOKUYAMA REBASE II

FDA 510(k)
FDA Class 2 ·Dental

FAS ENDOLUMINAL BRUSH

FDA 510(k)
FDA Class 2 ·General Hospital

MARGRON STEM (K032641)

FDA Adverse Event
Injury ·PORTLAND ORTHOPAEDICS PTY LTD·Product code KWY·May 31, 2005

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 17, 2025

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·June 7, 2022

VERSACARE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·March 19, 2013

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVAMEX·Product code IOR·September 5, 2014

DISPOSABLE PRESSURE TRANSDUCER

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 19, 2011

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