7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
MDx-Chex for BCN
FDA 510(k)
FDA Class 2
·Microbiology
Mfinity Femoral System
FDA 510(k)
FDA Class 2
·Orthopedic
VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr
FDA 510(k)
FDA Class 2
·Cardiovascular
SWEET PICOTIP RX
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code DTB·November 11, 2008
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·September 19, 2011
RSP SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·July 25, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025