9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INFINI RADIOFREQUENCY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOMERS TRANSLUCENT ORTHODONTIC BRACKET
FDA 510(k)
FDA Class 2
·Dental
BRESAGEN CATHETER, MODEL CS-3000
FDA 510(k)
FDA Class 2
·Neurology
ISOFLEX S
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·January 13, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 21, 2013
MAXIMO VR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·June 13, 2011
BD PHOENIX PANEL NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 31, 2024
PORTEX BLUE LINE ULTRA SUCTIONAID
FDA Adverse Event
Injury
·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code BTO·April 18, 2022
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025