8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THROMBOSCREEN THROMBOPLASTIN-DS
FDA 510(k)
FDA Class 2
·Hematology
VARIAX
FDA UDI
Stryker GmbH·07613327083125·Drawer Compression Plate
PORE-SI BONE GRAFT SUBSTITUTE
FDA 510(k)
FDA Class 2
·Orthopedic
AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
INTEGRATED APD SET W/CASSETTE3 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 29, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 17, 2014
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020