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

MEH 2022-08-04

Actera hip system

Applicant Conformis, Inc.

K-Number K221104

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PBF 2022-08-04

CenterMed Patient Matched Assisted Surgical Planning (ASP) System

Applicant Centermed, Inc.

K-Number K211614

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DSY 2022-08-04

exGraft, exGraft Carbon

Applicant Peca Labs

K-Number K221628

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QEW 2022-08-04

Mini-ClotTriever Thrombectomy System

Applicant Inari Medical

K-Number K220887

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QDD 2022-08-04

MDHearingAid app, MDHearingAid Smart hearing aids

Applicant Mdhearingaid

K-Number K220303

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DQA 2022-08-04

Masimo CARESCAPE SpO2 Masimo with SpHb

Applicant Masimo Corporation

K-Number K221953

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GWJ 2022-08-03

QScreen

Applicant Path Medical GmbH

K-Number K220139

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FRG 2022-08-03

Solidence Multipockets

Applicant Solidence Surgical Corporation

K-Number K191131

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QIH 2022-08-03

Customize

Applicant 3D-Side S.A.

K-Number K221432

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DHB 2022-08-03

ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed

Applicant Phadia AB

K-Number K212181

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EKZ 2022-08-03

Root ZX3

Applicant J. Morita USA, Inc.

K-Number K213477

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QDQ 2022-08-03

Transpara 1.7.2

Applicant Screenpoint Medical B.V.

K-Number K221347

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