10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN
FDA 510(k)
FDA Class 1
·Radiology
Nu-Edge Cobalt Chromium Brackets
FDA UDI
TP ORTHODONTICS INC·00192029047019·UL LAT
BeautiLink SA
FDA 510(k)
FDA Class 2
·Dental
VISU-LOCK 5MM CLIP APPLIER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INCEPTIV
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 11, 2025
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·December 14, 2010
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·January 29, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 14, 2014
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021