11 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CENTRIFUGAL PUMP SYSTEM LX/DX VERSION
FDA 510(k)
FDA Class 2
·Cardiovascular
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799008268·
Arthrex®
FDA UDI
ARTHREX, INC.·00888867472457·Cortical Screw, 2.7 mm x 58 mm
Arthrex®
FDA UDI
ARTHREX, INC.·00888867046979·LO-PRO SCRW TM SS 2.7X 58MMCORTEX
PRISMAFLO II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MCI - CMF System
FDA 510(k)
FDA Class 2
·Dental
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 10, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·October 22, 2010
BALANCED SALT SOLUTION
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code KYB·December 20, 2012
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 9, 2015
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026