13 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TheraFace LED
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoRoent
FDA UDI
Nuvasive, Inc.·00887517298577·CoRoent® XL-XW, 12x26x55mm 10°
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112908·CORNEAL TREPHINE BLADE7.25MM
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 29, 2014
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 8, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·November 9, 2015
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 20, 2023
COREVALVE TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 25, 2019
EVOLUT PRO TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 25, 2019
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 25, 2019
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021