20 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
EMIT VANCOMYCIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Precept
FDA UDI
Nuvasive, Inc.·00887517431196·PRECEPT Screw, 10.5x40mm Fixed
AlligatorTM
FDA UDI
Micro Therapeutics, Inc.·00847536014022·FA-88810-40 ALLIGATOR RETRIEVAL 4MM
Alligator
FDA UDI
Micro Therapeutics, Inc.·00836462014039·Retrieval Device
AlligatorTM
FDA UDI
Micro Therapeutics, Inc.·00847536013896·FA-88810-40 ALLIGATOR DEVICE ARD 4MM
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575315659·Orthopaedic implant inserter/extractor, reusabl...
LinkSymphoKnee - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575315710·Orthopaedic prosthesis implantation instrument,...
POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
FDA 510(k)
FDA Class 1
·General Hospital
CT SCANNER ND 8000
FDA 510(k)
FDA Class 2
·Radiology
NexGen®
FDA UDI
Zimmer, Inc.·00889024200050·
NexGen®
FDA UDI
Zimmer, Inc.·00889024200067·
NexGen®
FDA UDI
Zimmer, Inc.·00889024200081·
NexGen®
FDA UDI
Zimmer, Inc.·00889024200104·
NexGen®
FDA UDI
Zimmer, Inc.·00889024200074·
NexGen®
FDA UDI
Zimmer, Inc.·00889024200098·
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code NVY·January 13, 2014
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·October 18, 2010
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 14, 2012
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881040, 10mm, 5.5mm dia x 40mm, size: 10mm x 40mm, not for distribution in the U.S.A. or its territories, for spinal fixation.
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code NQP·November 12, 2007
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020