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

MAX 2020-03-02

CarboClear Lumbar Cage System

Applicant CarboFix Orthopedics , Ltd.

K-Number K193378

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LPN 2020-03-02

Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution

Applicant Menicon Co, Ltd.

K-Number K191872

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GAT 2020-03-02

High Strength Suture

Applicant Yunyi (Beijing) Medical Device Co., Ltd.

K-Number K192637

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LOL 2020-03-02

LIAISON Anti-HAV Assay

Applicant DiaSorin, Inc.

K-Number K193532

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LNH 2020-03-02

Vantage Galan 3T, MRT-3020, V6.0

Applicant Canon Medical Systems Corporation

K-Number K192506

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GEI 2020-03-02

BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider

Applicant Covidien, LLC

K-Number K193356

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CAW 2020-02-29

Kingon P2 Oxygen Concentrator

Applicant Qingdao Kingon Medical Science and Technology Co.

K-Number K190304

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QFM 2020-02-28

Red Dot

Applicant Behold.Ai Technologies Limited

K-Number K191556

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KGO 2020-02-28

SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)

Applicant Medline Industries, Inc.

K-Number K192820

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QJS 2020-02-28

Basal-IQ Technology

Applicant Tandem Diabetes Care, Inc.

K-Number K193483

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KGN 2020-02-28

scaffolene CL100 Bioresorbable Collagen Matrix

Applicant Freudenberg Technology Innovation SE & Co. KG

K-Number K192346

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LFL 2020-02-28

HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length

Applicant Ethicon Endo-Surgery, LLC

K-Number K191555

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