12 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BLUE POWER FREE NITRILE EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
MaxFuse VBR, 10 (D) x 12 (W) x 65 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468055844·10 (D) x 12 (W) x 65 (H)
PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
INNESIS PEEK CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 19, 2025
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929040799·Corpectomy, 12Dx14Wx64H 6°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929064986·Corpectomy, 12Dx14Wx64H 0°
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
SCD 700 COMPRESSION SYSTEM-US
FDA Adverse Event
Malfunction
·COVIDIEN·Product code JOW·September 26, 2014
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·June 7, 2011
REVEAL LINQ
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DSI·June 9, 2016
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