Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

DQK 2022-12-29

EndoPATx

Applicant Itamar Medical , Ltd.

K-Number K211557

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MHX 2022-12-29

Multi-Parameter Patient Monitor

Applicant Shenzhen Comen Medical Instruments Co.,Ltd

K-Number K211619

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FMI 2022-12-28

BD AutoShield Duo™ Pen Needle

Applicant Becton, Dickinson and Company

K-Number K223286

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EOB 2022-12-28

RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP

Applicant Olympus Medical Systems Corp.

K-Number K221660

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MAX 2022-12-28

Medussa-PL Cage

Applicant Medyssey USA, Inc.

K-Number K223654

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OWB 2022-12-28

nView s1 with nav option

Applicant Nview Medical

K-Number K221344

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MBB 2022-12-28

StageOne™ Select Hip Cement Spacer Molds

Applicant Biomet, Inc.

K-Number K222760

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QUW 2022-12-27

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device

Applicant Xiros, Ltd.

K-Number K222978

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DWJ 2022-12-27

IOB Warming Blankets

Applicant Iob Medical, Inc.

K-Number K221669

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DQK 2022-12-27

EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software License

Applicant ABBOTT MEDICAL

K-Number K223094

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DHA 2022-12-27

Access Total ßhCG (5th IS)

Applicant Beckman Coulter, Inc.

K-Number K221990

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HQF 2022-12-27

R:GEN

Applicant Lutronic Vision, Inc.

K-Number K220974

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