11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VIVALINK AED DEFIBRILLATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
3M™ ESPE™
FDA UDI
3M COMPANY·30605861031159·3M™ ESPE™ Gold Anodized Crown Refills, Second M...
AXSOS
FDA UDI
Stryker GmbH·07613327142808·Identification tag Compression Plate
EDENTA
FDA UDI
EDENTA ETABLISSEMENT·E312K90044510001·Dowel Pin 15 mm
DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC
FDA 510(k)
FDA Class 2
·Radiology
ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LIGASURE SMALL JAW
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·April 17, 2014
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·February 4, 2013
AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT
FDA Adverse Event
Malfunction
·UNITED STATES SURGICAL·Product code LFL·December 9, 2010
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
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026