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

FYA 2021-07-07

Surgical Gowns

Applicant Jiangsu Province Jianerkang Medical Dressing Co., Ltd.

K-Number K210215

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LLZ 2021-07-07

ONE Planner Hip

Applicant Orthosoft D/B/A Zimmer Cas

K-Number K210653

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LNH 2021-07-07

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

Applicant Hyperfine, Inc.

K-Number K211818

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FLL 2021-07-07

Infrared Forehead Thermometer

Applicant Shenzhen Combei Technology Co., Ltd.

K-Number K202741

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MAX 2021-07-07

Pantheon IBFD

Applicant Pantheon Spinal

K-Number K203003

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NXC 2021-07-06

TRIOCLEAR System

Applicant Perfection Aligner System Hong Kong Limited

K-Number K193622

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DYB 2021-07-06

SafeCross Transseptal Puncture and Introducer (TSP/I) System

Applicant East End Medical I, LLC

K-Number K203459

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KCT 2021-07-06

KARL STORZ Metal Sterilization Trays

Applicant Karl Storz Endoscopy America, Inc.

K-Number K203198

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DZE 2021-07-06

NUVO CF Implant System

Applicant JJGC Indústria e Comércio de Materiais Dentários S.A.

K-Number K203309

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MNR 2021-07-06

AcuPebble SA

Applicant Acurable Limited

K-Number K210480

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GEX 2021-07-06

DEKA Motus AZ

Applicant El.En Electronic Engineering Spa

K-Number K211821

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OLX 2021-07-02

RICOH MEG

Applicant Ricoh Company, Ltd.

K-Number K210199

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