8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Verifine® Ease Lancing Device, Verifine® Lancing Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MACROPORE SURGICAL BARRIER FILM
FDA 510(k)
FDA Class 2
·Ophthalmic
Sensatronic Reusable Temperature Probes
FDA 510(k)
FDA Class 2
·General Hospital
TENDRIL ST
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008
PRISM HTLV-I/HTLV-II
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code MTP·August 25, 2011
TRIATHLON PRIM TIB BASEPLATE - CEMENTED
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·July 12, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026