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

OLO 2020-01-17

Black Diamond Navigation Instruments

Applicant Osseus Fusion Systems

K-Number K192495

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PDU 2020-01-17

SoundBite Console, SoundBite Active Wire 18

Applicant Soundbite Medical Solution, Inc.

K-Number K192211

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NBW 2020-01-17

CareSens S Fit BT Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K-Number K193590

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GEX 2020-01-17

PicoLazer Laser System

Applicant Rohrer Aesthetics, LLC

K-Number K192583

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OAT 2020-01-17

Bio-TackS Orthodontic Mini Implant

Applicant Biocetec Co., Ltd.

K-Number K190871

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HIH 2020-01-16

Resectr Tissue Resection Device

Applicant Boston Scientific Corporation

K-Number K191538

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GEX 2020-01-16

Stellar M22 for Intense Pulsed Light (IPL) and Laser System

Applicant Lumenis, Ltd.

K-Number K193500

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QAJ 2020-01-16

INNOVO

Applicant Atlantic Therapeutics, Ltd.

K-Number K192357

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HGX 2020-01-16

Electric Breast Pump

Applicant Ningbo Huiyoo Baby Products Co., Ltd.

K-Number K191802

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MNR 2020-01-16

Maxxi Snore Sensor

Applicant Neurovirtual USA, Inc.

K-Number K191095

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MBI 2020-01-16

AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip

Applicant Parcus Medical, LLC

K-Number K192750

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GEI 2020-01-16

Viveve 2.0 System

Applicant Viveve Medical, Inc.

K-Number K193611

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