8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
EYE CARE CURE CONTACT LENS CASE
FDA 510(k)
FDA Class 2
·Ophthalmic
COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200
FDA 510(k)
FDA Class 2
·General Hospital
PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID
FDA 510(k)
FDA Class 2
·Dental
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·May 14, 2013
ECHELON MICROCATHETER
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code KRA·September 17, 2014
DURALOC SECTOR SERIES 54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 18, 2011
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