12 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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JIAJIAN POINTOSELECT DIGITAL
FDA 510(k)
FDA Class 2
·Neurology
Logical G-Series Acetabular Shell
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215054038·
Logical G-Series
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215006167·
POSISEP AND POSISEP X HEMOSTAT DRESSINGS
FDA 510(k)
FDA Unclassified
·Unknown
DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
FDA 510(k)
FDA Class 2
·Cardiovascular
VENTO Cup
FDA UDI
AMPLITUDE SAS·03701089514224·
U-BLADE SET, TI GAMMA3 10.5X90MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 30, 2012
STENOSCOP
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS·Product code JAA·May 17, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 27, 2014
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DTB·June 14, 2011
KINETRA
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·June 30, 2025
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