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

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Magicore System

FDA 510(k)
FDA Class 2 ·Dental

DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169524309·TRIAL 2152520 MEDIUM 12 DEGREES 20MM

LEONE SPA

FDA UDI
LEONE SPA·08033707014386·CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 20

Ophthalmic Forceps

FDA UDI
KATENA PRODUCTS, INC.·00841668106310·CASTROVIEJO FORCEPS 0.5MM

Trial Liners (20 degree hooded)

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215038731·

OrthoMedFlex

FDA UDI
ORTHOMEDFLEX LLC·M7161121525200·Trial Liner 20° 32/48-50 (B)

BD NEXIVA CLOSED IV CATHETER SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

VIRTUOSO DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 7, 2013

PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

FDA Adverse Event
Malfunction ·MEDELA, INC.·Product code HGX·October 6, 2014

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 27, 2011

BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·Product code FOZ·June 25, 2021

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

BD INTEGRA

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·November 17, 2023

ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·July 26, 2019

BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

Precise Treatment Table. To be used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 17, 2013