13 results · 21ms · Sources: EU EUDAMED, US FDA

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FDA 510(k)
FDA Class 2 ·Dental

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814657·GENUMEDI SILVER SIZE II

TENODESIS SCREW, PEEK

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code HWC·August 16, 2018

DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code MBI·August 16, 2018

GS 3000

FDA 510(k)
FDA Class 2 ·Physical Medicine

ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT

FDA 510(k)
FDA Class 2 ·Physical Medicine

FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY RIGHT ANGLE 5 MM

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code OWN·March 5, 2025

INTEGRITY AFX

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·January 13, 2014

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·August 4, 2011

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 20, 2013

VANTA

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 11, 2023

Niobe ES System, Models 001-006000-1 and 001-006100-1

FDA Enforcement
Class II ·Terminated·Stereotaxis Inc·November 18, 2020

TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems·October 10, 2018