9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Visby Medical Respiratory Health Test
FDA 510(k)
FDA Class 2
·Microbiology
DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OmniTom Elite
FDA 510(k)
FDA Class 2
·Radiology
OPTETRAK HI-FLEX TIBIAL INSERT
FDA Adverse Event
Other
·EXACTECH, INC.·Product code HSH·November 21, 2008
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
TARGET TIP
FDA Adverse Event
Death
·MPRI·Product code DTB·July 23, 2013
XVWEB
FDA Adverse Event
Injury
·PLANET DDS·Product code LLZ·March 13, 2025
SECOND OPINION
FDA Adverse Event
Injury
·PEARL INC.·Product code MYN·March 13, 2025
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026