11 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
i-Sil
FDA 510(k)
FDA Class 2
·Dental
TENSION SLEEVE 4mm
FDA UDI
Aktormed GmbH·04260463847741·
THREADED STEINMANN PINS, DOUBLE END BAYONET POINT
FDA UDI
Biomet Orthopedics, LLC·00887868016639·
MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)
FDA 510(k)
FDA Class 1
·Ophthalmic
NFIX II PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZOLL IVTM QUATTRO CATHETER
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code NCX·January 12, 2022
ASCEND HIGH OFFSET HUMERAL HEAD
FDA Adverse Event
Injury
·TORNIER INC·Product code KWT·June 6, 2013
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·July 8, 2011
SIGMA 300 D
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·October 10, 2014
BD¿ NEXIVA SINGLE PORT
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 21, 2019
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
FDA Enforcement
Class II
·Terminated·Cardiovascular Systems Inc·May 31, 2017