15 results · 20ms · 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.

CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS

FDA 510(k)
FDA Class 2 ·Dental

BILOX PROSTHESIS HEAD 12/14 28MM L

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

CANNULATED SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO SKYLIGHT IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

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

TOTAL ASR FEM IMP SIZE 51

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KXA·April 29, 2013

MAXCEM ELITE

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

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Injury ·ROCHE DIAGNOSTICS·Product code LFR·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

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