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

BZD 2020-06-02

F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K200089

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JOF 2020-06-02

StarPore

Applicant Anatomics Pty, Ltd.

K-Number K200532

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NUC 2020-06-02

Bunny Wax Personal Lubricant

Applicant Reoxcyn, LLC

K-Number K192779

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OLO 2020-06-02

HIP7

Applicant Brainlab AG

K-Number K193307

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NKB 2020-06-02

Altus Spine Pedicle Screw System

Applicant Altus Partners, LLC

K-Number K200322

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LLZ 2020-06-02

MI View&GO

Applicant Siemens Medical Solutions USA, Inc.

K-Number K201202

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PGY 2020-06-02

iMac 27 & PL 4.0

Applicant Quantum-Spectra, LLC

K-Number K200889

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HRS 2020-06-01

Skeletal Dynamics Forearm Plating System

Applicant Skeletal Dynamics, Inc.

K-Number K200538

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CAC 2020-06-01

ProCell Surgical Sponge-Blood Recovery Unit

Applicant Procell Surgical, Inc.

K-Number K193361

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JOH 2020-06-01

Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff

Applicant Covidien

K-Number K193077

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FRC 2020-06-01

3MTM AttestTM Rapid 5 Steam-Plus Test Pack

Applicant 3M Complany

K-Number K200536

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GBM 2020-06-01

Jimushi Sterile Urethral Catheter for single use

Applicant Hangzhou Jimushi Meditech Co., Ltd.

K-Number K200134

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