Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

MAX 2016-04-15

Leva Spacer System

Applicant Spine Wave, Inc.

K-Number K153222

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KOC 2016-04-15

CRIT-LINE III Blood Chamber II

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K160749

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MRG 2016-04-15

Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators

Applicant Fujirebio Diagnostics,Inc.

K-Number K153361

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GEX 2016-04-15

SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber

Applicant Surgical Laser Incorporated

K-Number K151855

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MNR 2016-04-15

BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal

Applicant Salter Labs

K-Number K151874

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IPF 2016-04-15

StimSox(TM) System

Applicant Stimmed, LLC

K-Number K151922

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HKY 2016-04-15

Applanation Tonometer

Applicant Shanghai Mediworks Precision Instruments Co. , Ltd.

K-Number K142263

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DXQ 2016-04-14

Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff

Applicant Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd.

K-Number K153251

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LZA 2016-04-14

Nitrile Patient Examination gloves, Powderfree, Blue color

Applicant Primus Gloves Pvt Limited

K-Number K143477

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OHT 2016-04-14

iPulse SmoothSkin Gold Hair Removal Device

Applicant Cyden Limited

K-Number K160968

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KIF 2016-04-14

Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes

Applicant Sybron Dental Specialties

K-Number K152959

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PGY 2016-04-14

CX30N (CX30PQX)

Applicant Wide Corporation

K-Number K160348

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