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

MQL 2020-07-17

Synvitro Hyadase

Applicant Origio A/S, A Coopersurgical Company

K-Number K200680

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FTL 2020-07-17

3DMax MID Anatomical Mesh

Applicant C.R. Bard, Inc.

K-Number K200818

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HSB 2020-07-17

Phantom® Hindfoot TTC/TC Nail System

Applicant Paragon 28, Inc.

K-Number K201227

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OWN 2020-07-17

Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head

Applicant Olympus Medical Systems Corp.

K-Number K200542

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LLZ 2020-07-17

True 3D Viewer

Applicant Echopixel, Inc.

K-Number K201365

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GEX 2020-07-16

AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories

Applicant Lumenis, Ltd.

K-Number K201663

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KGN 2020-07-16

KeraStat Cream

Applicant Keranetics

K-Number K192386

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OQG 2020-07-16

KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System

Applicant Kyocera Medical Technologies, Inc.

K-Number K201660

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QFM 2020-07-16

HealthMammo

Applicant Zebra Medical Vision, Ltd.

K-Number K200905

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DXN 2020-07-16

Arm Blood Pressure Monitor

Applicant Ningbo Ranor Medical Science & Technology Co., Ltd.

K-Number K193456

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JDI 2020-07-16

ZCA All-Poly Acetabular Cups

Applicant Zimmer, Inc.

K-Number K191449

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KWT 2020-07-16

TiN Coated Humeral Head

Applicant Fx Shoulder USA, Inc.

K-Number K191698

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