8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM)
FDA 510(k)
FDA Class 2
·Orthopedic
TI COLLAR WITH GROOVES
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012
da Vinci Xi Surgical System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS
FDA 510(k)
FDA Class 2
·Microbiology
ATTAIN STARFIX
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 9, 2013
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 2, 2014
UNICEL® DXC 800 PRO SYNCHRON ® CHEMISTRY ANALYZER
FDA Adverse Event
BECKMAN COULTER INC.·Product code JJE·January 6, 2011
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024