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

LPH 2017-10-02

Trident® II Acetabular System

Applicant Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

K-Number K171768

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HWC 2017-10-02

Large Screws Range

Applicant Newclip Technics

K-Number K172596

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IPF 2017-10-02

Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10

Applicant Shenzhen Dongdixin Technology Co., Ltd.

K-Number K171978

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ODG 2017-09-29

Endoscopic Ultrasound Aspiration Needle

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K172309

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GWJ 2017-09-29

SmartEP

Applicant Intelligent Hearing Systems

K-Number K163326

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LLZ 2017-09-29

ASPIRE Bellus II

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

K-Number K171463

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IYN 2017-09-29

U2 Diagnostic Ultrasound System

Applicant Edan Instruments, Inc.

K-Number K172380

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CCJ 2017-09-29

Carbon Monoxide Breath Sensor System (COBSS)

Applicant Carrot Sense, Inc.

K-Number K171408

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KGO 2017-09-29

Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim

Applicant Wear Safe (Malaysia) Sdn. Bhd.

K-Number K172420

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LHI 2017-09-29

Arisure Dry Spike

Applicant Yukon Medical

K-Number K172631

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OCC 2017-09-29

Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

Applicant Alere Scarborough, Inc.

K-Number K171792

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GAM 2017-09-29

CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture

Applicant Cpt Sutures Co., Ltd.

K-Number K170166

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