51 results · 25ms · Sources: EU EUDAMED, US FDA

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DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal Reflection Fluorescence and localization microscopy may be used to examine a variety of samples over long periods of time.

FDA Recall
Terminated ·GE Healthcare Biosciences·Product code REM·September 10, 2018

The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.

FDA Recall
Terminated ·Ormco/Sybronendo·Product code EJF·April 24, 2012

Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.

FDA Recall
Terminated ·On-X Life Technologies, Inc.·Product code PAW·December 13, 2016

On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

FDA Recall
Open, Classified ·On-X Life Technologies, Inc.·Product code LWQ·February 1, 2026

Recreo Hair Growth Laser Comb

FDA Recall
Open, Classified ·OMM Imports, Inc. dba Zero Gravity·Product code OAP·September 1, 2022

Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<7.5K EX/Y The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

FDA Recall
Terminated ·Carestream Health Inc.·Product code LLZ·September 16, 2013

Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

FDA Recall
Terminated ·Carestream Health Inc.·Product code LLZ·September 16, 2013

Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 25K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

FDA Recall
Terminated ·Carestream Health Inc.·Product code LLZ·September 16, 2013

Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

FDA Recall
Terminated ·Carestream Health Inc.·Product code LLZ·September 16, 2013

Carestream Vue PACS; MX WEB SW/ 1 MX-O CONCUR ACCESS LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

FDA Recall
Terminated ·Carestream Health Inc.·Product code LLZ·September 16, 2013

Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 50K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

FDA Recall
Terminated ·Carestream Health Inc.·Product code LLZ·September 16, 2013

Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

FDA Recall
Terminated ·Carestream Health Inc.·Product code LLZ·September 16, 2013

Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

FDA Recall
Terminated ·Carestream Health Inc.·Product code LLZ·September 16, 2013

Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

FDA Recall
Terminated ·Carestream Health Inc.·Product code LLZ·September 16, 2013

Carestream Vue PACS; MX WEB SW/1 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

FDA Recall
Terminated ·Carestream Health Inc.·Product code LLZ·September 16, 2013

Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

FDA Recall
Terminated ·Carestream Health Inc.·Product code LLZ·September 16, 2013

Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

FDA Recall
Terminated ·Carestream Health Inc.·Product code LLZ·September 16, 2013

BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.

FDA Recall
Terminated ·Becton Dickinson and Company·Product code HMX·September 15, 2008

VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461

FDA Recall
Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code HMX·December 17, 2019

ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.

FDA Recall
Terminated ·Ellex iScience, Inc.·Product code HMX·January 11, 2018