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

MAX 2021-05-06

CONDUIT Instruments

Applicant Medos International SARL

K-Number K210728

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EBI 2021-05-05

GR-14 Resin System

Applicant Pro3Dure Medical GmbH

K-Number K210298

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NUW 2021-05-05

D function

Applicant Ito Co., Ltd.

K-Number K203525

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QDD 2021-05-05

Bose SoundControl Hearing Aids

Applicant Bose Corporation

K-Number K211008

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ISA 2021-05-05

OrthoGold 100

Applicant Tissue Regeneration Technologies, LLC

K-Number K210451

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KTT 2021-05-05

OIC External Fixation System

Applicant Orthopaedic Implant Company

K-Number K211112

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JWH 2021-05-05

Genius / Genuin Total Knee System

Applicant Biorad Medisys Pvt, Ltd.

K-Number K200765

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BTA 2021-05-04

Medline Vacu-line Suction Aspirator

Applicant Medline Industries, Inc.

K-Number K203135

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DTX 2021-05-04

Quantum Mini Ventilation Module

Applicant Spectrum Medical , Ltd.

K-Number K210669

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LHI 2021-05-04

ProntoPump Sterile Tube Set

Applicant Ipax, Inc.

K-Number K200893

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NLH 2021-05-04

Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)

Applicant Innovative Health, LLC

K-Number K203655

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HAE 2021-05-04

Rebellion, Phantom Multi-Bite Kerrison Rongeur

Applicant Morpheus AG

K-Number K200768

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