13 results · 19ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

THE PFT FILTER

FDA 510(k)
FDA Class 2 ·Anesthesiology

RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE

FDA 510(k)
FDA Class 1 ·General Hospital

EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

PLATE, FIXATION, BONE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HRS·November 16, 2015

4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/45MM

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HWC·December 9, 2015

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·April 29, 2013

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 13, 2011

MONOPOLAR CURVED SCIESSORS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC.·Product code GEI·July 24, 2008

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·September 1, 2016

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·December 4, 2015

4.0MM CANCELLOUS BONE SCREW FULLY THREADED/45MM

FDA Adverse Event
Injury ·SYNTHES GRENCHEN·Product code HWC·December 18, 2015

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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