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

NXC 2022-08-31

MyClearALIGN Dental Aligner System

Applicant Key Dental Technologies, LLC

K-Number K221475

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NKB 2022-08-31

Sterile Posterior Spinal Fixation System

Applicant Shanghai Reach Medical Instrument Co, Ltd.

K-Number K221745

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PDU 2022-08-31

LimFlow ARC

Applicant LimFlow, Inc.

K-Number K221541

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LHI 2022-08-31

Vented Vial Adapter 20mm

Applicant West Pharma. Services IL, Ltd.

K-Number K213513

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HRS 2022-08-31

I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)

Applicant I.T.S. GmbH

K-Number K210935

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MUH 2022-08-31

Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20

Applicant Realcloud Imaging Inc. Dba Realcloud Imaging

K-Number K221955

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OHT 2022-08-31

IPL sapphire ice cooling hair remove device

Applicant Shenzhen Desida Technology Co., Ltd.

K-Number K221635

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PHX 2022-08-31

INHANCETM Reverse Glenoid Peripheral Posts

Applicant Depuy Ireland UC

K-Number K221467

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EBF 2022-08-31

SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow

Applicant Kerr Corporation

K-Number K221255

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LNH 2022-08-31

Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K222387

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IYO 2022-08-31

QT Scanner 2000 Model A

Applicant Qt Imaging, Inc.

K-Number K220933

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QRK 2022-08-31

Disposable Blood Lancet

Applicant SteriLance Medical (Suzhou), Inc.

K-Number K221507

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