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

CCK 2021-03-04

Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+

Applicant Unimed Medical Supplies, Inc.

K-Number K210019

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DXC 2021-03-04

V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186

Applicant Carefusion 2200, Inc.

K-Number K210324

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DXC 2021-03-04

MI DeTACH

Applicant Biorep Technologies, Inc.

K-Number K210006

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MQB 2021-03-03

Mars 1417X Wireless Digital Flat Panel Detector

Applicant Iray Technology Taicang , Ltd.

K-Number K210316

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MAX 2021-03-03

FORZA Ti Spacer System

Applicant Orthofix, Inc.

K-Number K203576

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QJP 2021-03-03

TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform

Applicant Imperative Care, Inc.

K-Number K203764

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NTE 2021-03-03

WIRION Embolic Protection System

Applicant Cardiovascular Systems, Inc.

K-Number K210282

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JSM 2021-03-03

Cultura Collection and Transport System

Applicant Merit Medical Systems, Inc.

K-Number K201674

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FRC 2021-03-03

EOGas 4 Endo-SteriTest RRBI

Applicant Andersen Sterilizers, Inc.

K-Number K202879

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NPL 2021-03-03

Geistlich Mucograft®, Geistlich Mucograft® Seal

Applicant Geistlich Pharma AG

K-Number K210280

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KPS 2021-03-03

Biograph Vision Quadra PET/CT System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K210262

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PZX 2021-03-03

AtriClip LAA Exclusion System

Applicant AtriCure, Inc.

K-Number K210293

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