10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY Reader (43220); ULTRA GI Process Challenge Device (PCD) (43400)(30 count)
FDA 510(k)
FDA Class 2
·General Hospital
M.U.S.T. PEDICLE SCREWS SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·November 10, 2025
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
FDA 510(k)
FDA Class 2
·Radiology
HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·January 13, 2026
M.U.S.T. PEDICLE SCREWS SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·November 10, 2025
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEM·November 4, 2008
ASR ACETABULAR IMPLANT 44
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 6, 2011
SYSTEM 6 ASEPTIC HOUSING ASSY
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code KIJ·July 18, 2013
M.U.S.T. SACRAL ILIAC SCREW AND PELVIC TRAUMA SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OUR·October 16, 2024