16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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