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

FDS 2016-03-03

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1

Applicant Fujifilm Medical System U.S.A., Inc.

K-Number K153206

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LFL 2016-03-03

Tenex Health TX System

Applicant Tenex Health, Inc.

K-Number K153299

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PGY 2016-03-03

Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21

Applicant Qingdao Hisense Medical Equipment Co., Ltd.

K-Number K160347

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MHX 2016-03-03

Passport Series Patient Monitors (Including Passport 8, Passport 12)

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K153448

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JZO 2016-03-03

IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K152061

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EZD 2016-03-03

FULL CARE Disposable PVC Nelaton Catheter

Applicant Shaoxing Fuqing Health Products Co., Ltd.

K-Number K151745

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GAT 2016-03-03

Dunamis Force DFX Tensile Tape

Applicant Dunamis, LLC

K-Number K153746

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HWC 2016-03-02

RECON system - Compression Screws

Applicant Normed Medizin-Technik GmbH

K-Number K151708

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PBY 2016-03-02

Sentimag System, Sentimark Magnetic Marker Systerm

Applicant Endomagnetics Ltd.,

K-Number K153044

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MNH 2016-03-02

Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System

Applicant Captiva Spine

K-Number K160020

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HAW 2016-03-02

Leksell Stereotactic System, Injection/ Aspiration Needle Kit

Applicant Elekta Instrument AB

K-Number K152558

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DQA 2016-03-02

Finger Type Pulse Oximeter

Applicant Taidoc Technology Corporation

K-Number K151024

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