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

FXX 2022-12-16

Surgical Mask

Applicant Wuhan Zonsen Medical Products Co., Ltd.

K-Number K213601

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LKF 2022-12-16

Rejoni Intrauterine Catheter

Applicant Rejoni, Inc.

K-Number K222798

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MAX 2022-12-16

Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K223153

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MWI 2022-12-15

VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor

Applicant Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.

K-Number K221267

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LZA 2022-12-15

Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs

Applicant Grand Work Plastic Products Co., Ltd.

K-Number K222892

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NFB 2022-12-15

Proxima

Applicant Dynasthetics, LLC

K-Number K220591

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DRE 2022-12-15

TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)

Applicant Spectranetics, Inc.

K-Number K223472

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LHN 2022-12-15

Small Field Applicator

Applicant Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

K-Number K220883

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LFL 2022-12-15

LOTUS Series 4 Enhanced Shears, LOTUS Series 5

Applicant Sra Developments, Ltd.

K-Number K221102

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BZQ 2022-12-15

Dozee VS

Applicant Turtle Shell Technologies Private Limited

K-Number K221555

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FXX 2022-12-15

PM Excellence SEQUR 100 Surgical Face Mask

Applicant Pm Excellence, LLC

K-Number K220520

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ELW 2022-12-15

Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty

Applicant Genoss Co., Ltd.

K-Number K214086

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