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

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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MAX 2021-05-06

CONDUIT Instruments

Applicant Medos International SARL

K-Number K210728

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EBI 2021-05-05

GR-14 Resin System

Applicant Pro3Dure Medical GmbH

K-Number K210298

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NUW 2021-05-05

D function

Applicant Ito Co., Ltd.

K-Number K203525

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QDD 2021-05-05

Bose SoundControl Hearing Aids

Applicant Bose Corporation

K-Number K211008

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ISA 2021-05-05

OrthoGold 100

Applicant Tissue Regeneration Technologies, LLC

K-Number K210451

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KTT 2021-05-05

OIC External Fixation System

Applicant Orthopaedic Implant Company

K-Number K211112

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JWH 2021-05-05

Genius / Genuin Total Knee System

Applicant Biorad Medisys Pvt, Ltd.

K-Number K200765

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