24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
FDA 510(k)
FDA Class 2
·Orthopedic
Implant Prosthetics
FDA UDI
Preat Corporation·00842092138281·Multi-Unit Tall Titanium Base w/ .048 Hex Screw
Preat Implant Prosthetics
FDA UDI
Preat Corporation·00842092165126·Multi-Unit Tall Titanium Base w/.048 Screw
Kit ...
INSET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 19, 2025
CLARREN HELMET
FDA 510(k)
FDA Class 2
·Neurology
ASCENT XXL OPEN BOX FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 8, 2024
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 8, 2024
DELTA CUP ACCESSORIES
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code LPH·October 8, 2025
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 19, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 19, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 19, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 19, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 19, 2024
ENDEAVOR RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·March 14, 2013
EON RECHARGEABLE IPG, 16-CHANNEL
FDA Adverse Event
Injury
·ST. JUDE MEDICAL -NEUROMODULATION DIV.·Product code LGW·February 23, 2011
ATLAS20CM
FDA Adverse Event
Malfunction
·COVIDIEN LP (US SURGICAL)·Product code GEI·February 20, 2008
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·May 5, 2021
LOGIC FEMORAL PS CEM LEFT SZ 3
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 21, 2024
2.7X8MM HT X-DRIVE SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·August 4, 2016