14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CT Perfusion V1.0
FDA 510(k)
FDA Class 2
·Radiology
BD Difco™ Bordetella pertussis Antiserum
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902230915·BD Difco™ Bordetella Pertussis Antiserum
GOMCO
FDA UDI
Allied Medical, LLC·00026072001844·SUCTION PRESSURE UNIT, 309, PORTABLE
TriVerse Modular Tray Trial
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215097721·
VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T
FDA 510(k)
FDA Class 2
·Radiology
ST AIA-PACK TESTOSTERONE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
BONESCALPEL® HANDPIECE
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·April 6, 2023
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·November 4, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCO·Product code CBK·August 10, 2011
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 12, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
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