11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CITIEFFE-TITANIUM CANNULATED SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
5530 3L SYRINGE
FDA UDI
HANS RUDOLPH, INC.·00817136021034·5530 3L SYRINGE: NDD EASYONE
DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
COLLACARE DENTAL
FDA 510(k)
FDA Unclassified
·Unknown
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 20, 2022
GALILEO ECHO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·May 15, 2013
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·May 25, 2011
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
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