17 results · 20ms · Sources: EU EUDAMED, US FDA

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Lotus Posterior Cervical/Thoracic Spinal System

FDA 510(k)
FDA Class 2 ·Orthopedic

Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089476657·

Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089476817·

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100233·LIEBERMAN ASPIRATING SPECULUM V-WIRE

Cadet Cervical Cage

FDA UDI
VALORUS SPINE LLC·00811771033438·Cadet Cervical Cage, 15mm x 17mm x 05mm, Non-Lo...

Cadet Cervical Cage

FDA UDI
VALORUS SPINE LLC·00811771034060·Cadet Cervical Cage, 15mm x 17mm x 05mm, 7° Lor...

MISTRAL-AIR WARMING SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

IPS E.MAX CAD/IPS E.MAX ZIRCAD

FDA 510(k)
FDA Class 2 ·Dental

CONCERTO CRT-D DR

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

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

CLAMP

FDA Adverse Event
Malfunction ·MCROBERTS SECURITY TECHNOLOGIES·Product code HFW·June 27, 2011

Implantable Chest Ports With PASV Valve Technology - Dual Lumen - PASV Port/10/DL/T/PA Catalog Number: PRTB10P

FDA Recall
Terminated ·Boston Scientific Corporation·Product code KOB·July 22, 2005

Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 20, 2013

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

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

All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 12, 2014

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

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

Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020