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

IYN 2018-01-11

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4

Applicant Toshibamedical Systems Corporation

K-Number K173090

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KRA 2018-01-11

Microcatheter and guide-wire system

Applicant Suzhou Hengrui Disheng Medical Co., Ltd.

K-Number K171665

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DPS 2018-01-11

Digital Electrocardiograph

Applicant Biocare Bio-Medical Equipment Co., Ltd.

K-Number K171517

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OBR 2018-01-11

Bruxor

Applicant Sleep Specialties, LLC

K-Number K172452

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CFF 2018-01-11

HYDRASHIFT 2/4 daratumumab, daratumumab Control

Applicant Sebia

K-Number K172195

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LLZ 2018-01-11

DTX Studio diagnose

Applicant Nobel Biocare AB

K-Number K172224

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BZH 2018-01-11

Besmed Peak Flow Meter

Applicant Besmed Health Business Corp

K-Number K172804

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FEO 2018-01-10

Swiss LithoClast Trilogy

Applicant E.M.S Electro Medical Systems S.A

K-Number K173234

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MQF 2018-01-10

Guardia Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter

Applicant Cook Incorporated

K-Number K172051

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JWH 2018-01-10

Smith & Nephew Patient Matched Cutting Blocks

Applicant Smith & Nephew, Inc.

K-Number K172336

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DQX 2018-01-10

Amplatz Support Wire Guide with Apex Curve

Applicant Cook Incorporated

K-Number K171445

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DXC 2018-01-10

ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE

Applicant Tz Medical, Inc.

K-Number K173563

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