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