174 results · 18ms · Sources: EU EUDAMED, US FDA

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X-Guide Handpiece Adaptor Sleeve 3, Model P010727

FDA Recall
Open, Classified ·X-NAV Technologies, LLC·Product code QRY·March 4, 2024

X-Guide Handpiece Adaptor Sleeve 1, Model P010701

FDA Recall
Open, Classified ·X-NAV Technologies, LLC·Product code QRY·March 4, 2024

X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673

FDA Recall
Open, Classified ·X-NAV Technologies, LLC·Product code QRY·September 28, 2022

ARIES System and ARIES M1 System

FDA Recall
Terminated ·Luminex Corporation·Product code OOI·April 19, 2017

Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017

FDA Recall
Terminated ·Luminex Corporation·Product code OOI·June 29, 2018

ARIES HSV 1&2 Assay, Part Number/REF 50-10017

FDA Recall
Terminated ·Luminex Corporation·Product code OOI·April 16, 2021

HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.

FDA Recall
Terminated ·Catheter Research, Inc·Product code HGS·April 7, 2015

ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073

FDA Recall
Open, Classified ·Luminex Corporation·Product code OOI·February 20, 2019

ARIES HSV 1&2 Assay, Catalog/REF# 50-10017

FDA Recall
Terminated ·Luminex Corporation·Product code OOI·November 17, 2021

Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457.

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·May 1, 2011

Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS.

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·April 6, 2010

ARIES SARS-CoV-2 Assay

FDA Recall
Open, Classified ·Luminex Corporation·Product code QJR·July 14, 2022

Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452

FDA Recall
Open, Classified ·Luminex Corporation·Product code OZZ·February 20, 2019

ARIES SARS-CoV-2 Assay, REF: 50-10047

FDA Recall
Open, Classified ·Luminex Corporation·Product code QJR·September 14, 2022

ARIES GBS Assay , REF 50-10021, UDI # 00840487100165

FDA Recall
Open, Classified ·Luminex Corporation·Product code NJR·February 20, 2019

ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295

FDA Recall
Open, Classified ·Luminex Corporation·Product code PGI·February 20, 2019

ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059

FDA Recall
Open, Classified ·Luminex Corporation·Product code OZN·February 20, 2019

ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469

FDA Recall
Open, Classified ·Luminex Corporation·Product code PGX·February 20, 2019

ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158

FDA Recall
Open, Classified ·Luminex Corporation·Product code OZE·February 20, 2019

Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.

FDA Recall
Terminated ·Iris Diagnostics·Product code JJW·September 18, 2012