19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EXPEDIUM SFX CROSS CONNECTOR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Sportex
FDA UDI
Diversified Products, Inc.·00037741407089·
Clear Readers
FDA UDI
Diversified Products, Inc.·00842894153314·
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108699197·Titanium Base Abutment Round Anterior, Int. Hex...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702407594·Elvarex 2/Knee High/Slant-Closed Toe/Dotted sil...
Matira
FDA UDI
Kalitec Direct LLC·B073K0730000·Plate Bender, Universal
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0103000·Caddie, Domino Connectors
MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
FDA 510(k)
FDA Class 2
·Neurology
LIGHTSPEED 2.0CT SCANNER SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
AFP ¿1-FETOPROTEIN
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LOJ·July 22, 2016
XIENCE XPEDITION
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code NIQ·August 11, 2020
CONFIDENCE KIT, NO NEEDLES
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NDN·April 1, 2014
XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code NIQ·February 9, 2021
UNKNOWN OPTEASE VENA CAVA FILTER
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code DTK·April 22, 2013
TECNIS CL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·April 18, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEM INC.·Product code JAA·July 9, 2008
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022