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

HRX 2020-12-21

Resascope RS-01/B

Applicant Advanced Medical Systems Group Srl

K-Number K201113

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ISD 2020-12-21

MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra

Applicant Lode B.V.

K-Number K202979

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GAM 2020-12-21

Monocryl Plus Antibacterial Suture

Applicant ETHICON, Inc.

K-Number K201996

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INI 2020-12-21

Wu's Electrical Scooter

Applicant Wu'S Tech Co., Ltd.

K-Number K192308

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MLY 2020-12-21

num Vapocoolant

Applicant 623 Medical, LLC

K-Number K202782

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DSH 2020-12-20

Strados Remote Electronic Stethoscope Platform (RESP)

Applicant Strados Labs

K-Number K201077

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JOW 2020-12-20

Flexitouch Plus System

Applicant Tactile Systems Technology, Inc. (Dba Tactile Medical)

K-Number K203178

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KGO 2020-12-19

Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein

Applicant Medline Industries, Inc.

K-Number K202668

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FMI 2020-12-19

NovoFine Plus 32G Tip x 4 mm

Applicant Novo Nordisk, Inc.

K-Number K202005

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IYE 2020-12-18

ClearRT Helical kVCT for the Radixact Treatment Delivery System

Applicant Accuray Incorporated

K-Number K202412

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FLL 2020-12-18

Infrared Thermometer

Applicant Contec Medical Systems Co.,Ltd

K-Number K201980

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OWB 2020-12-18

Alphenix, INFX-8000V/B, /S, V9.1

Applicant Canon Medical Systems Corporation

K-Number K203551

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