8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Gafchromic™
FDA UDI
ASHLAND SPECIALTY INGREDIENTS G.P.·00850000065895·Blood Irradiation Indicator
AMERLITE TT3 ASSAY, LAN.0003/1003/2003
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STENOSCOP
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 19, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAH
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·January 18, 2011
M2A-MAGNUM MODULAR HEAD SZ 48MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·August 1, 2014
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026