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

OAP 2021-06-29

Biophotas Celluma RESTORE

Applicant Biophotas, Inc.

K-Number K211038

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MUJ 2021-06-29

RayStation 10.1

Applicant RaySearch Laboratories AB (PUBL)

K-Number K210645

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OHS 2021-06-29

Synergy

Applicant Yrs Group, Inc.

K-Number K210954

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IYN 2021-06-29

Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40

Applicant Supersonic Imagine

K-Number K203645

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LZA 2021-06-28

White Nitrile Powder Free Patient Examination Glove, Non Sterile

Applicant Onetexx Sdn Bhd

K-Number K210775

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PNR 2021-06-28

ENFit Disposable Enteral Syringe

Applicant Shantou Wealy Medical Instrument Co.,Ltd

K-Number K203410

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EBF 2021-06-28

Diafil & Diafil Capsule

Applicant DiaDent Group International

K-Number K210421

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HSB 2021-06-28

Phantom Hindfoot TTC/TC Nail System

Applicant Paragon 28, Inc.

K-Number K210869

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DZJ 2021-06-28

CenterMed Patient Matched Assisted Surgical Planning (ASP) System

Applicant Centermed, Inc.

K-Number K201353

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LZA 2021-06-28

Violet Nitrile Powder Free Patient Examination Glove, Non Sterile

Applicant Onetexx Sdn Bhd

K-Number K210587

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INI 2021-06-25

Scooter (Model: FDB01)

Applicant Nanjing Jin Bai HE Medical Apparatus Co., Ltd.

K-Number K201196

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NDN 2021-06-25

SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement

Applicant Stryker Instruments

K-Number K211238

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