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 2018-11-16

REDAPT Modular Acetabular Shell

Applicant Smith & Nephew, Inc.

K-Number K182109

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EXB 2018-11-16

SmartBag (SmartPouch)

Applicant 11 Health Technologies Limited

K-Number K181643

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ODP 2018-11-16

Axis Chena Cervical PEEK Spacer System

Applicant Axis Orthopaedics

K-Number K181140

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MJN 2018-11-16

Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr

Applicant Lemaitre Vascular

K-Number K182916

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POV 2018-11-16

LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer

Applicant Bonraybio Co., Ltd.

K-Number K180343

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LZA 2018-11-16

Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)

Applicant Hartalega Sdn Bhd

K-Number K180645

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BTL 2018-11-16

SafeT T-Piece Resuscitator

Applicant Ventlab, LLC

K-Number K173373

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JAK 2018-11-16

Celesteion, PCA-9000A/3, V6.5

Applicant Canon Medical Systems Corporation

K-Number K181646

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MOS 2018-11-16

1.5T 16ch Breast Coil

Applicant Neocoil, LLC

K-Number K182958

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GKR 2018-11-16

hemochroma PLUS System

Applicant Immunostics Inc.,

K-Number K182298

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HRS 2018-11-16

Stratum Foot Plating System

Applicant Nextremity Solutions, Inc.

K-Number K182201

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FGE 2018-11-16

Zilver 518 Biliary Stent, Zilver 635 Biliary Stent

Applicant Cook Ireland, Ltd.

K-Number K182980

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