32 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XSTAT 30, 3-PACK, XSTAT 30, 1-PACK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Signature Femoral Head
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215001957·
Paxeon Femoral Head
FDA UDI
PAXEON RECONSTRUCTION LLC·08177570200177·Paxeon Head, Ceramic Size 32mm XL
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161111526240·Ceramic Femoral Head, 32mm, XL (+7.0 mm)
AVITA WRIST TYPE BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
SIGNATURE Head - BIOLOX Delta
FDA UDI
AMPLITUDE SAS·03701089520782·
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 10, 2020
PENUMA IMPLANT
FDA Adverse Event
Injury
·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 7, 2013
PENUMBRA SYSTEM SEPARATOR 032
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·June 22, 2011
AXSYM RUBELLA IGG ANTIBODY
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code LFX·September 10, 2008
CD HORIZON® FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·September 3, 2024
CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code NKB·July 28, 2025
CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code NKB·July 28, 2025
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·April 25, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·January 4, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·February 18, 2019
CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·April 2, 2025
CD HORIZON® SOLERA® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., HU·Product code NKB·March 20, 2026