72 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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QUIDEL Sofia SARS Antigen FIA IVD REF 20374
FDA Recall
Terminated
·Quidel Corporation·Product code PSZ·September 25, 2020
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
FDA Enforcement
Class II
·Terminated·Quidel Corporation·November 18, 2020
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
FDA Recall
Terminated
·Quidel Corporation·Product code GNX·December 3, 2012
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
FDA Enforcement
Class II
·Terminated·Quidel Corporation·February 20, 2013
CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024
FDA Recall
Terminated
·Neuro-Fitness LLC·Product code JXK·October 29, 2007
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
FDA Recall
Terminated
·Quidel Corporation·Product code QKP·September 17, 2020
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
FDA Enforcement
Class II
·Terminated·Quidel Corporation·October 28, 2020
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
FDA Recall
Terminated
·Medtronic Inc.·Product code MDS·July 15, 2020
ReadyMed Elastomeric Ambulatory Pump, Model Numbers: R050050, R100100, R100200, R250050, R250100, and R250167. Intended for self-administration of anti-microbial and antiviral agents.
FDA Recall
Terminated
·Cardinal Health 303 dba Cardinal Health·Product code FRN·December 19, 2008
Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod Pediatric LT with Trailing Anti-Tipper-Caster-Axle Link, Freedom Designs Incorporated, Simi Valley, CA 93065
FDA Recall
Terminated
·Freedom Designs Inc·Product code IOR·May 14, 2007
MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.
FDA Recall
Terminated
·Medtronic Inc.·Product code OZO·May 8, 2017
MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760.
FDA Recall
Terminated
·Medtronic Inc.·Product code OZP·May 8, 2017
MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.
FDA Recall
Terminated
·Medtronic Inc.·Product code OZO·May 8, 2017
Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures, for pre-implant and peri-implant surgery and for covering bone defects and empty sockets.
FDA Recall
Terminated
·Inion Ltd. Laakarinkatu 2 FIN-33520 Tampere Finland·Product code NPK·March 1, 2017
MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1551, MMT-1751, MMT-1552, MMT-1752.
FDA Recall
Terminated
·Medtronic Inc.·Product code OZP·May 8, 2017
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 55, Catalog Number LG-PR0855, Allez Spine, LLC., Irvine, CA
FDA Recall
Terminated
·Allez Spine, LLC·Product code MNI·July 30, 2007
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 80, Catalog Number LG-PR0880, Allez Spine, LLC., Irvine, CA
FDA Recall
Terminated
·Allez Spine, LLC·Product code MNI·July 30, 2007
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 45, Catalog Number LG-PR0845, Allez Spine, LLC., Irvine, CA
FDA Recall
Terminated
·Allez Spine, LLC·Product code MNI·July 30, 2007
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 35, Catalog Number LG-PR0835, Allez Spine, LLC., Irvine, CA
FDA Recall
Terminated
·Allez Spine, LLC·Product code MNI·July 30, 2007
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 50, Catalog Number LG-PR0850, Allez Spine, LLC., Irvine, CA
FDA Recall
Terminated
·Allez Spine, LLC·Product code MNI·July 30, 2007