15 results · 22ms · 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.

NEUROSCAPE

FDA 510(k)
FDA Class 2 ·Radiology

BILOX PROSTHESIS HEAD 12/14 28MM L

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·May 23, 2014

AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

BIOLOX PROSTHESIS HEAD 12/14 28MM S

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012

BIOLOX PROSTHESIS HEAD 12/14 28MM S

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 14, 2014

BIOLOX PROSTHESIS HEAD 12/14 28MM M

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012

BIOLOX PROSTHESIS HEAD 12/14 32MM L

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014

BIOLOX PROSTHESIS HEAD 12/14 28MM S

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·April 29, 2013

MAXCEM ELITE

FDA Adverse Event
Injury ·KERR CORPORATION·Product code EMA·May 10, 2011

UNKNOWN DEPUY TIBIAL TRAY

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSH·July 28, 2008

MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·October 23, 2013

IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

FDA Enforcement
Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 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