15 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CAPSURE(R) PS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MAXCUT CARBIDE BUR (100/pk) FG 6
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811119131·MAXCUT CARBIDE BUR (100/pk) Shape: Round; Size:...
TI TITAMAX EX IMPLANT (4.1)3.75X9
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·November 9, 2017
ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM
FDA 510(k)
FDA Class 2
·Dental
SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES
FDA 510(k)
FDA Class 2
·Physical Medicine
HAHN TAPERED IMPLANT Ø5.0 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 13, 2023
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 13, 2024
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 7, 2013
ASCENSIA BREEZE2
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·August 8, 2008
APEX BALLOON CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·June 2, 2011
HAHN TAPERED IMPLANT Ø5.0 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·December 8, 2022
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 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