10 results · 20ms · Sources: EU EUDAMED, US FDA

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FRAMELOCK; FRAMELOCK ACCESSORIES

FDA 510(k)
FDA Class 2 ·Neurology

nSpire Health

FDA UDI
NSPIRE HEALTH, INC.·00852417003118·Bronchial Challenge Kit, Disposable (single pat...

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 8, 2026

SOLARA JR. MANUAL WHEELCHAIR

FDA 510(k)
FDA Class 1 ·Physical Medicine

XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BHR

FDA Adverse Event
Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 27, 2013

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWP·March 17, 2011

PRECISION XTRA/OPTIUM

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·March 27, 2008

8300 ALARIS ETCO2 MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code CCK·November 12, 2020

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