9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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URINE REAGENT STRIP-3 PARAMETERS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ANCHORAGE
FDA UDI
Stryker GmbH·07613327171297·Screw Rack CP
THE STRAUMANN ORTHO IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MR SYRINGE DUAL PACK
FDA 510(k)
FDA Class 2
·Cardiovascular
OPERATING CYSTOSCOPE-URETHROSCOPE
FDA Adverse Event
Death
·KARL STORZ SE & CO. KG·Product code FGB·March 8, 2023
INFINITI VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 17, 2010
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2014
LIGASURE IMPACT THORACIC
FDA Adverse Event
Malfunction
·COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC·Product code GEI·December 19, 2012
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