Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

MLY 2022-05-25

CRYO Arctic, CRYO Penguin

Applicant Cryoscience North America, Inc.

K-Number K203661

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EBF 2022-05-25

OptiComp

Applicant Pac-Dent, Inc.

K-Number K202920

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DXH 2022-05-25

KardiaMobile 6L

Applicant AliveCor, Inc.

K-Number K220350

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GEI 2022-05-25

Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)

Applicant Stryker Sustainability Solutions

K-Number K220481

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GZJ 2022-05-25

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)

Applicant Bozhou Rongjian Medical Appliance Co., Ltd.

K-Number K220578

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QNQ 2022-05-25

LDV((Low Dead Volume )Syringe

Applicant Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

K-Number K220083

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NKB 2022-05-25

CD Horizon Spinal System

Applicant Medtronic

K-Number K221244

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KWD 2022-05-25

restor3d MTP Implant

Applicant Restor3D, Inc.

K-Number K201393

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LLZ 2022-05-25

SwiftMR

Applicant Airs Medical, Inc.

K-Number K220416

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FLL 2022-05-25

Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E

Applicant Shenzhen AOJ Medical Technology Co., Ltd.

K-Number K213485

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GCJ 2022-05-25

780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable

Applicant Stryker

K-Number K214046

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GEI 2022-05-25

Renuvion Dermal Handpiece, Renuvion Dermal System

Applicant Apyx Medical Corporation (Formerly Bovie Medical Corporation

K-Number K211652

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