23 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

SYMETREX LONG TERM HEMODIALYSIS CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

STRYKER KNIFELIGHT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CPELVISOFT ACELLULAR COLLAGEN BIOMESH

FDA Adverse Event
Injury ·TISSUE SCIENCE LABORATORIES·Product code FTM·May 24, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 27, 2011

9600EMI

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008

SILVERHAWK ATK

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MCW·April 8, 2024

CXI SUPPORT CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code KRA·April 18, 2019

CXI SUPPORT CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·March 2, 2020

CXI SUPPORT CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·March 18, 2021

CXI SUPPORT CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·April 21, 2021

CXI SUPPORT CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·June 21, 2019

CXI SUPPORT CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·January 25, 2024

CXI SUPPORT CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code KRA·January 29, 2019

CXI SUPPORT CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·March 12, 2020

CXI SUPPORT CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code KRA·March 12, 2020

CXI SUPPORT CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code KRA·December 8, 2022

CXI SUPPORT CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·March 31, 2022

CXI SUPPORT CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·October 10, 2019

Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·September 26, 2012