19 results · 22ms · Sources: EU EUDAMED, 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