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

MOF 2020-09-25

Synchro SELECT Guidewire

Applicant Stryker Neurovascular

K-Number K202522

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LZH 2020-09-25

PUGGLE Enteral Feeding Pump and Feeding Set

Applicant Amsino International, Inc.

K-Number K200051

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BZL 2020-09-25

Breezing Med

Applicant Tf Health Co.

K-Number K200076

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MAX 2020-09-25

NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System

Applicant Nu Vasive, Incorporated

K-Number K201820

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JDG 2020-09-25

Distal Centralizers

Applicant Biomet, Inc.

K-Number K193546

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LPH 2020-09-24

Cordera Hip System

Applicant Conformis, Inc.

K-Number K202484

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KPR 2020-09-24

GXR-Series Diagnostic X-Ray System

Applicant DRGEM Corporation

K-Number K202572

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QMM 2020-09-24

Tangible Boost

Applicant Tangible Science, Inc.

K-Number DEN200002

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ELW 2020-09-24

A-Silicone for Bite Registration

Applicant Shandong Huge Dental Material Corporation

K-Number K201684

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DQA 2020-09-24

Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor

Applicant Masimo Corporation

K-Number K201770

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GEH 2020-09-24

Dermal Cooling System

Applicant R2 Technologies, Inc.

K-Number K201260

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LYC 2020-09-24

Straumann BoneCeramic

Applicant Institut Straumann AG

K-Number K201051

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