25 results · 25ms · Sources: EU EUDAMED, US FDA

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PROFYLE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM)

FDA 510(k)
FDA Class 2 ·Dental

DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

BHR MODULAR HEAD 46MM

FDA Adverse Event
Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code KWY·January 4, 2018

GRAFTYS HBS (510K NUMBER: K082498)

FDA Adverse Event
Injury ·GRAFTYS·Product code MQV·July 11, 2013

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·December 17, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·May 7, 2009

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC·Product code KWP·August 11, 2009

56MM AND R3 ACETABULAR SHELL

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·March 19, 2010

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·August 2, 2013

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 1, 2016

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 17, 2013

ROTATING MULTIPLE CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 19, 2011

ARTICULEZE M HEAD 36MM +1.5

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code JDI·June 17, 2008

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 6, 2013

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·December 22, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·December 22, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWQ·November 2, 2009

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·December 11, 2017