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

GCJ 2022-06-17

SPY Laparoscope

Applicant Stryker

K-Number K221217

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PPW 2022-06-17

CipherOx CRI Tablet

Applicant Flashback Technologies, Inc.

K-Number K213255

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JFB 2022-06-17

Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702

Applicant Ceragem Co., Ltd.

K-Number K220572

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LZA 2022-06-17

Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile

Applicant One Glove Industrial Sdn Bhd

K-Number K220431

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HRS 2022-06-17

Baby Gorilla/Gorilla Plating System

Applicant Paragon 28, Inc.

K-Number K221465

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DQO 2022-06-17

Langston dual lumen catheter

Applicant Vascular Solutions, LLC

K-Number K221470

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QKB 2022-06-17

ART-PLAN

Applicant Therapanacea

K-Number K220813

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IYE 2022-06-17

ARIA Radiation Therapy Management (v16.1 MR3)

Applicant Varian Medical Systems, Inc.

K-Number K221408

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IYN 2022-06-17

RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K221117

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IPF 2022-06-17

MyOnyx System

Applicant Thought Technology , Ltd.

K-Number K213197

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GEH 2022-06-17

Freeze’n Clear Skin Clinic Warts & Tags

Applicant Cryoconcepts LP

K-Number K211099

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LLZ 2022-06-17

ElucidVivo A.3

Applicant Elucid Bioimaging, Inc.

K-Number K221463

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