11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Gating Reflector Block
FDA 510(k)
FDA Class 2
·Radiology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·14026704920690·
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704266610·FRAZIER SUCTION TUBES 7.5" ANGLED 9 FRENCH
ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)
FDA 510(k)
FDA Class 2
·Cardiovascular
Puritan Bennett Cuff Pressure Manager
FDA 510(k)
FDA Class 2
·Anesthesiology
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNETT CORP.·Product code CBK·November 19, 2008
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
UPHOLD? LITE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTP·July 23, 2013
HELICAL BLADE INSERTER
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·April 10, 2019
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024