11 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ONLINE TDM Phenytoin - Free Phenytoin application
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BD Difco™ Salmonella O Antiserum Group C3 Factors (8), 20
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902301615·BD Difco™ Salmonella O Antiserum Group C3 Facto...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780183631·Integra® Jarit® Cushing Rongeur, 8", 6mm Bite, ...
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573020379·INTRG WHISP-Z ROTH 1BICHK -17T 0A 022 LR
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776353223·Cushing Rongeur, curved,
SUPERBOND
FDA 510(k)
FDA Class 2
·Dental
PASSEO-35
FDA 510(k)
FDA Class 2
·Cardiovascular
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014
UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JGS·September 1, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 16, 2013
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014