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

KPR 2022-04-19

General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)

Applicant Xera Medical Systems & Technology , Ltd.

K-Number K220149

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OVD 2022-04-19

Altus Spine Interbody Standalone Fusion System

Applicant Altus Partners, LLC

K-Number K211837

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NKG 2022-04-19

Infinity OCT System and PASS OCT Spinal System

Applicant Medicrea International

K-Number K220810

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NDN 2022-04-18

KYPHON VuE Bone Cement

Applicant Tecres S.P.A.

K-Number K220131

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LCM 2022-04-18

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair

Applicant Psychemedics Corporation

K-Number K212952

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JAA 2022-04-18

Nautilus

Applicant Dornier Medtech America, Inc.

K-Number K220871

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LZA 2022-04-17

BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free

Applicant Meditech Gloves Sdn Bhd

K-Number K213408

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QIH 2022-04-15

AI-Rad Companion Brain MR

Applicant Siemens Healthcare GmbH

K-Number K213706

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MUJ 2022-04-15

RayStation 11B

Applicant RaySearch Laboratories AB (PUBL)

K-Number K220141

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GEX 2022-04-15

mJOULE System and Accessories

Applicant Sciton, Inc

K-Number K213350

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LLZ 2022-04-15

XD

Applicant Mirada Medical, Ltd.

K-Number K220779

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MBI 2022-04-15

FootHold System

Applicant Crossroads Extremity Systems, LLC

K-Number K220797

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