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

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DANEK PLATE AND SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CAPSTONE® Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994290977·SPACER 2991036 CAPSTONE PEEK 10X36

Scott's Select RC Cream 2-9gm Syringe

FDA UDI
PRIME DENTAL·00817441023549·Scott's Select RC Cream 2-9gm Syringe

Zavation

FDA UDI
Zavation LLC·00842166121553·Straight Bone Probe

TAUB - Trident - IMPULSE

FDA UDI
Taub Products·D8379910360·This is a chisel tip for removing cemented crow...

SyMRI

FDA 510(k)
FDA Class 2 ·Radiology

FETASONDE UTERINE WORK MONITOR

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

NexGen® Complete Knee Solution

FDA UDI
Zimmer, Inc.·00889024224476·

COLORADO 2 SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code MNH·December 4, 2009

COLORADO II SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code MNH·May 19, 2017

COLORADO SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·October 17, 2016

ACCU-CHEK ® INFORM METER

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·March 6, 2013

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·August 8, 2014

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

COLORADO II SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·July 26, 2011

Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

FDA Enforcement
Class II ·Terminated·Philips North America, LLC·March 25, 2020