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

GEH 2021-05-06

Dr. Yglo Wart Remover

Applicant Theotclab Healthcare B.V.

K-Number K210529

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GEI 2021-05-06

CoolSeal Reveal

Applicant Bolder Surgical, LLC

K-Number K203640

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KPE 2021-05-06

SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL

Applicant Gilero, LLC

K-Number K201936

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JWH 2021-05-06

Identity Imprint Knee Replacement System

Applicant Conformis, Inc.

K-Number K210191

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IPF 2021-05-06

Talent-Pro Electromagnetic Stimulator

Applicant Remed Co., Ltd.

K-Number K202031

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FOS 2021-05-06

Umbilical Vessels Catheter

Applicant Haolang Medical USA Corporation

K-Number K201697

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FXX 2021-05-06

3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3

Applicant 3A Medical Products Co., Ltd.

K-Number K202598

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ODC 2021-05-06

AutoCap RX

Applicant Boston Scientific Corporation

K-Number K210353

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MUJ 2021-05-06

Corvus Radiation Therapy Planning System

Applicant Best Nomos

K-Number K211034

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FXX 2021-05-06

Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3

Applicant Defender Safety, Inc.

K-Number K210705

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HRS 2021-05-06

DRPx Locking Distal Radius Plate System

Applicant Orthopaedic Implant Company

K-Number K202971

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LOX 2021-05-06

KardiFlex NC Coronary Dilatation Catheter

Applicant Medcaptain Life Science Co., Ltd.

K-Number K202578

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