11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
FDA 510(k)
FDA Class 2
·Radiology
M.U.S.T. PEDICLE SCREWS SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·November 10, 2025
Q-Rejuvalight Pro Facewear (Model: P19-0023)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Disposable Laparoscopic Trocar
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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
ALINITY C CALCIUM2
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CJY·March 5, 2026
ASR ACETABULAR IMPLANT 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 6, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2014
JOSTENT GRAFTMASTER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·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