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

OLO 2021-09-27

Dark Star Navigation Instrument System

Applicant Republic Spine, LLC

K-Number K212028

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FLL 2021-09-26

DT100 Digital Thermometer

Applicant Smart Technology Co., Ltd.

K-Number K203731

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FXX 2021-09-26

Surgical Mask

Applicant Sichuan Prius Biotechnology Co., Ltd.

K-Number K210908

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BSP 2021-09-26

DiscCath Needle Set

Applicant Disccath, LLC

K-Number K212328

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CAH 2021-09-26

Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter

Applicant Pharma System AB

K-Number K202459

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KGO 2021-09-26

Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove

Applicant Cardinal Health200, LLC

K-Number K201592

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OWB 2021-09-24

Virtual C DRF-NEO Digital Imaging System

Applicant Portavision Medical, LLC

K-Number K212557

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NUC 2021-09-24

Personal Lubricant

Applicant Shenzhen Huanqiu Xuebao Technology Co., Ltd.

K-Number K210857

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DIO 2021-09-24

DRI Cocaine Metabolite Assay

Applicant Microgenics Corporation

K-Number K211973

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MEH 2021-09-24

Encore Hip Stem

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K211505

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LLZ 2021-09-24

Collaboration Live

Applicant Philips Ultrasound, Inc.

K-Number K212777

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DZE 2021-09-24

Nobel Biocare Dental Implant Systems Portfolio - MR Conditional

Applicant Nobel Biocare AG

K-Number K212125

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