Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

MAX 2022-11-07

WaveForm A Interbody System

Applicant SeaSpine Orthopedics Corporation

K-Number K222732

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DQY 2022-11-07

Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system

Applicant Medtronic

K-Number K222873

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DXN 2022-11-07

HemoSphere Advanced Monitor, HemoSphere ClearSight Module

Applicant Edwards Lifesciences, LLC

K-Number K221833

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HIS 2022-11-07

Durex Patronus CloseFit, Durex Patronus Regular

Applicant Rb Health (Us), LLC

K-Number K220489

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KRA 2022-11-07

Vericor Support Catheter

Applicant Vascupatent Medical (Shenzhen) Co., Ltd.

K-Number K222679

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MWJ 2022-11-07

Eclipse MINI Model 98900

Applicant Spacelabs Healthcare, Ltd.

K-Number K212317

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EGS 2022-11-07

Smooth Drive contra angle and straight handpieces

Applicant Lares Research

K-Number K220874

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ELW 2022-11-07

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)

Applicant Hdi, Inc.

K-Number K222741

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QDZ 2022-11-05

Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack

Applicant Diasorin Molecular, LLC

K-Number K202755

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JWH 2022-11-04

World Total Knee System

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K223062

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HWC 2022-11-04

Nextra CH Cannulated Hammertoe System

Applicant Nextremity Solutions, Inc.

K-Number K221610

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QJP 2022-11-04

BENCHMARK BMX81 Access System

Applicant Penumbra, Inc.

K-Number K221822

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