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

OWN 2021-11-15

KARL STORZ ICG Imaging System

Applicant Karl Storz Endoscopy America

K-Number K212695

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MQB 2021-11-15

ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)

Applicant H&abyz Co., Ltd.

K-Number K213497

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IYN 2021-11-15

Clarius Ultrasound Scanner

Applicant Clarius Mobile Health Corp.

K-Number K213436

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LFL 2021-11-15

Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device

Applicant Covidien, LLC

K-Number K212301

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IYO 2021-11-15

Axialis Ophthalmic Ultrasound System

Applicant Quantel Medical

K-Number K213254

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EIH 2021-11-15

Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Applicant Bloomden Bioceramics (HuNan) Co., Ltd.

K-Number K212765

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OHV 2021-11-15

SofWave System

Applicant Sofwave Medical, Ltd.

K-Number K211483

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GEX 2021-11-15

Darwin

Applicant Luvo Medical Technologies, Inc.

K-Number K212607

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NHA 2021-11-15

DS Implants abutments provided with the EV connection

Applicant Dentsply Sirona

K-Number K213449

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IRP 2021-11-15

Air Compression Massager (Model LF-FT003)

Applicant Wenzhou Lingfeng Electronic Technology Co., Ltd.

K-Number K213000

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JOW 2021-11-15

Circul8 Pro

Applicant Ortho8, Inc.

K-Number K212731

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FXX 2021-11-14

Spin Care Disposable Protective Mask Level 3

Applicant Spintech, LLC

K-Number K212109

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