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

LNH 2017-11-21

LiverMultiScan

Applicant Perspectum Diagnostics, Ltd.

K-Number K172685

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LPH 2017-11-21

Smith & Nephew, Inc. REDAPT Augments

Applicant Smith & Nephew, Inc.

K-Number K171073

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DQX 2017-11-21

TXM Hydrophilic Guidewire

Applicant Texasmedical Technologies, Inc.

K-Number K170915

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ODP 2017-11-21

Altus Spine Cervical Interbody Fusion System

Applicant Altus Partners, LLC

K-Number K172253

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KOD 2017-11-21

GentleCath Intermittent Urinary Catheter

Applicant Convatec Limited

K-Number K172924

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DZE 2017-11-21

S.I.N. Dental Implant System

Applicant S.I.N. – Sistema DE Implante Nacional S.A.

K-Number K170398

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FRO 2017-11-21

3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing

Applicant 3M Company, 3M Healthcare

K-Number K170754

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GEI 2017-11-21

LAP-iX

Applicant Sejong Medical Co., Ltd.

K-Number K173112

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MQE 2017-11-21

Follicle Aspiration Set, Reduced Single Lumen

Applicant Vitrolife Sweden AB

K-Number K172050

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FRO 2017-11-21

Microcyn Antimicrobial Skin and Wound Cleanser

Applicant Sonoma Pharmaceuticals

K-Number K172622

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DYB 2017-11-21

Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath

Applicant Terumo Medical Corporation

K-Number K172995

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DXN 2017-11-21

Automatic Wrist Bluetooth Blood Pressure Monitor

Applicant Truly Instrument , Ltd.

K-Number K170545

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