15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
XENX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Multi Hub Assembly
FDA UDI
Noras MRI products GmbH·04251269202339·
TRAPSYSTEM SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 9, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 14, 2024
ACTICON NEOSPHINCTER
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code MIP·May 10, 2013
PROVISIONAL PLUG DRIVER-LONG
FDA Adverse Event
Malfunction
·ZIMMER SPINE, INC.·Product code MAX·September 17, 2014
OCTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 2, 2011
SURGIQUEST AIRSEAL
FDA Adverse Event
Injury
·SURGIQUEST, INC.·Product code GCJ·September 25, 2014
SURGIQUEST AIRSEAL
FDA Adverse Event
Injury
·SURGIQUEST, INC.·Product code GCJ·March 11, 2015
SURGIQUEST AIRSEAL
FDA Adverse Event
Other
·SURGIQUEST, INC.·Product code HIF·December 12, 2013
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025