8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COMET CAPNOGRAPH MODULE
FDA 510(k)
FDA Class 2
·Anesthesiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122970·K-WIRE - SINGLE TROCAR 1.1mm DIA x 150mm
FSH MENOPAUSE PREDICTOR TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MATRIXWAVE MMF SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ITREL 3
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·December 22, 2010
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 18, 2013
ACCU-CHEK ® SPIRIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·July 17, 2014
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026