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

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PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set

FDA 510(k)
FDA Class 2 ·General Hospital

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704285376·

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100318·ALPHONSO INFANT SPECULUM

EVEREST SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

AMPLATZER SIZING BALLOON II

FDA 510(k)
FDA Class 2 ·Cardiovascular

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., HU·Product code KWP·October 17, 2025

VITALITY 2

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 7, 2011

INSYNC MAXIMO

FDA Adverse Event
Injury ·IPG MFG SWITZERLAND·Product code NIK·June 8, 2013

RESERVOIR 3ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 8, 2014

CD HORIZON BALLAST SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·December 9, 2019

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Injury ·COOK INC·Product code DYB·October 29, 2025

FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

FDA Adverse Event
Injury ·COOK INC·Product code DYB·October 29, 2025

DYB INTRODUCER, CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code DYB·November 12, 2025

FLEXOR SHUTTLE SELECT GUIDING SHEATH

FDA Adverse Event
Injury ·COOK INC·Product code DYB·October 29, 2025

UNKNOWN

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·September 15, 2020

FLEXOR SHUTTLE SELECT GUIDING SHEATH

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·February 7, 2020

ASAHI CONQUEST PRO 9-40

FDA Adverse Event
Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·April 27, 2016

StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.

FDA Enforcement
Class II ·Terminated·Dental EZ Stardental Division·June 19, 2013

ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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