15 results · 26ms · Sources: EU EUDAMED, US FDA

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SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DIAMOND SETUP 2000

FDA 510(k)
FDA Class 2 ·Radiology

CD HORIZON SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC

FDA Adverse Event
Injury ·COOK INC·Product code LJS·December 3, 2015

UNKNOWN PATHINDER NXT OR INSTINCT JAVA IMPLANT

FDA Adverse Event
Malfunction ·ZIMMER BIOMET SPINE INC.·Product code NKB·September 24, 2022

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 29, 2013

POLYHESIVE RETURN ELECTRODE

FDA Adverse Event
Malfunction ·COVIDIEN LP·Product code GEI·October 1, 2014

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·June 17, 2011

DEKA MOTUS AX

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 25, 2018

ROD, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019

PEDICLE SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019

PEDICLE SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019

DEKA MOTUS AX

FDA Adverse Event
Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·March 9, 2023

DEKA MOTUS AX

FDA Adverse Event
Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·February 6, 2024

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012