ARTICLE SUMMARY:
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in December 2022. Updated December 31.
A roundup of FDA’s actions in December 2022.
NOVEL DEVICE APPROVALS |
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Company |
Device |
Date |
Approval Type |
Approval Number |
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Endomagnetics | magtracetm and sentimag(r) magnetic locatization system | 12/6/2 | Panel-track supplement | P160053 S002 |
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Resolution Bioscience | resolution ctdx first | 12/12/22 | Original PMA | P210040 | ||||
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flexability ablation catheter, sensor enabled | 12/14/22 | Panel-track supplement | P110016 S080 | ||||
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Tornier Pyrocarbon Humeral Head | 12/16/22 | De Novo | DEN220012 | ||||
Foundation Medicine | foundationone liquid cdx (f1lcdx) | 12/22/22 | Panel-track supplement | P190032 S004 | ||||
Nanovi | BioXmark | 12/23/22 | De Novo | DEN220017 | ||||
BREAKTHROUGH DEVICES |
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Sponsor |
Device | Clinical Target |
Date |
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Click Therapeutics | CT-132 digital therapeutic | Episodic migraine | 12/19/22 | |||||
WARNING LETTERS |
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Company |
Citations |
Posting Date |
Issuing Office |
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Premarket (COVID-19) |
12/27/22 | OHT7: Office of In Vitro Diagnostics | ||||||
RoyalVibe Health | Premarket | 12/27/22 | OHT 4: Office of Surgery and Infection Control Devices |
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CLASS 1 RECALLS |
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Company |
Device |
Date |
Recall Number |
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Caire |
CAIRE Liberator Liquid Oxygen System Unit, var. models | 12/1/22 | Z- 0336-2023 through Z-0339-2023 | |||||
Remel | Thermo SCIENTIFIC, Sensititre Gram Negative IVD AST, var. |
12/8/22 | Z-0327-2023 through Z-0335-2023 | |||||
Arrow International | Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit |
12/10/22 | Z-0352-2023 | |||||
Arrow International | Arrow MAC Two-Lumen Central Venous Access Kit | 12/10/22 |
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Arrow International | Arrow AutoCAT2 Intra-aortic balloon pumps, var. | 12/15/22 | Z-0426-2023 through Z-0456-2023 | |||||
NEW DIAGNOSTIC EMERGENCY USE AUTHORIZATIONS |
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Test Kit Manufacturer & Commercial Labs |
Date |
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Diazyme Laboratories, Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit |
12/6/22 | |||||||
ACON Laboratories, Flowflex COVID-19 Antigen Rapid Test | 12/6/22 | |||||||
Life Technologies, TaqPath Monkeypox/Orthopox Virus DNA Kit | 12/13/22 | |||||||
OnSiteGene, Hi-Sense COVID-19 Molecular Testing Kit 1.0 | 12/19/22 | |||||||
CTK Biotech, ImmuView COVID-19 Antigen Home Test | 12/20/22 | |||||||
Oceanit Foundry, ASSURE-100 Rapid COVID-19 Home Test | 12/22/22 | |||||||
Advin Biotech, Advin COVID-19 Antigen Test @Home | 12/22/22 | |||||||
Visby Medical, Visby Medical Respiratory Health Test | 12/23/22 | |||||||
BD, VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System | 12/23/22 |