11 results · 26ms · Sources: EU EUDAMED, US FDA

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CUDA SURGICAL LIGHT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MOR® Implant 3.0 X 13mm, Ti

FDA UDI
STERNGOLD DENTAL LLC·00841549108259·The MOR is a self-tapping, small diameter, scre...

HERO VASCULAR ACCESS DEVICE

FDA 510(k)
FDA Class 2 ·Cardiovascular

QUICKIE 2 POWER ASSIST WHEELCHAIR

FDA 510(k)
FDA Class 2 ·Physical Medicine

AMS MINIARC SLING SYSTEM

FDA Adverse Event
Injury ·AMERICAN MEDICAL SYSTEMS·Product code PAH·June 30, 2014

BIVONA CUSTOM 3.0 FLEXTEND TRACHEOSTOMY TUBE

FDA Adverse Event
Malfunction ·SIMTHS MEDICAL ASD, INC.·Product code JOH·November 9, 2010

HUDSON MICRO MIST NEBULIZER

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code CAF·January 3, 2013

FT3 - FREE TRIIODOTHYRONINE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code CDP·October 10, 2014

FT4, FREE THYROXINE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code CEC·September 30, 2016

Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 6, 2016

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