9 results
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27ms
·
Sources: EU EUDAMED, US FDA
TITANIUM BIPOLAR FORCEPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANCHORAGE
FDA UDI
Stryker GmbH·07613327171327·Implant Module
BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS
FDA 510(k)
FDA Class 2
·Immunology
PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300
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
DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
FDA Adverse Event
Malfunction
·SYNTHES JENNERSVILLE·Product code HTJ·February 4, 2013
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·December 20, 2010
OCTRODE
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 18, 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