15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NovoFine® Plus
FDA 510(k)
FDA Class 2
·General Hospital
Regatta Lateral System
FDA UDI
Seaspine Orthopedics Corporation·10889981158996·Lateral Implant, 23mm x 12mm x 55mm, 10 Deg
Regatta Lateral System
FDA UDI
Seaspine Orthopedics Corporation·10889981159009·Lateral Implant, 23mm x 12mm x 55mm, 15 Deg
RRx Knee Tibial Cone Augment Reamer Size Large
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215147860·
TSolution® One Total Knee Application
FDA 510(k)
FDA Class 2
·Neurology
Surgical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 26, 2022
Vu aPod™ - L
FDA UDI
Seaspine Orthopedics Corporation·10889981046712·LATERAL IMPLANT, WIDE, LORDOTIC, 12mm X 23mm X ...
T:SLIM G4 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·June 21, 2018
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·April 14, 2011
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·September 1, 2011
UNKNOWN DEPUY BONE CEMENT
FDA Adverse Event
Injury
·9610921 DEPUY CMW·Product code LOD·July 17, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025