17 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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