11 results
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19ms
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Sources: EU EUDAMED, US FDA
R1596 POWERED EXERCISE EQUIPMENT
FDA 510(k)
FDA Class 1
·Physical Medicine
VITEK 2 GRAM POSITIVE VRSA SCREEN
FDA 510(k)
FDA Class 2
·Microbiology
Signia sterilization tray
FDA 510(k)
FDA Class 2
·General Hospital
HYPODERMIC NEEDLE PRO SYRINGE AND NEEDLE WITH NEEDLE PROTECT
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FMI·September 25, 2006
GORE® TRI-LOBE BALLOON CATHETER
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·February 26, 2016
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2014
TOTAL ASR FEM IMP SIZE 53
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·December 7, 2012
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 23, 2015
GORE® TAG® THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·February 26, 2016
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012