24 results · 22ms · Sources: EU EUDAMED, 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