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

GKR 2019-02-01

HemoCue Hb 801 System

Applicant Hemocue AB

K-Number K181751

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OCX 2019-02-01

Glo-Tip Spray Catheter

Applicant Wilson-Cook Medical, Inc.

K-Number K182319

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NKB 2019-02-01

Pedimax II - Pedicular Screw Spinal System

Applicant Gm Dos Reis Industria E Comerico Ltda.

K-Number K180626

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PBX 2019-02-01

Family of Venus RF Systems - Heal

Applicant Venus Concept USA, Inc.

K-Number K182094

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GDW 2019-02-01

easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use

Applicant Ezisurg Medical Co., Ltd.

K-Number K181657

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GGM 2019-02-01

HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High

Applicant Eurotrol B.V.

K-Number K182744

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NBW 2019-02-01

iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)

Applicant Andon Health Co, Ltd.

K-Number K181070

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IZF 2019-02-01

DR 800 with Tomosynthesis

Applicant Agfa N.V.

K-Number K183275

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GEX 2019-02-01

Vbeam Prima Laser System

Applicant Candela Corp.

K-Number K183452

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LLZ 2019-02-01

AI Rad Companion (Engine)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K183272

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HIH 2019-01-31

Endosee System

Applicant CooperSurgical, Inc.

K-Number K183020

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MUH 2019-01-31

Panoura X-ERA PF/NF/MF

Applicant The Yoshida Dental Mfg. Co., Ltd.

K-Number K182198

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