18 results · 23ms · Sources: EU EUDAMED, US FDA

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PathLoc-SI Joint Fusion System

FDA 510(k)
FDA Class 2 ·Orthopedic

Midmark

FDA UDI
MIDMARK CORPORATION·00841709107160·Track/Trolley Assembly used on the Track Mounte...

TYRX ANTIMICROBIAL MESH

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

THERMO SCIENTIFIC MAS R DOA TOTAL

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

FORMATK MAGMA PLATFORM LASER

FDA Adverse Event
Injury ·FORMATK SYSTEMS LTD.·Product code GEX·December 19, 2019

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 18, 2019

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 28, 2024

VERTEX® RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·August 16, 2017

FORMATK MAGMA PLATFORM

FDA Adverse Event
Malfunction ·FOMATK SYSTEMS, LTD·Product code GEX·January 8, 2020

VERTEX® RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 3, 2017

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·October 18, 2018

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MPRI·Product code DTB·June 8, 2013

VITALITY

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 7, 2011

GE OEC 9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 11, 2008

VERTEX® RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 17, 2017

MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 7, 2019

VERTEX® RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·July 15, 2024

ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023