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

NHA 2024-09-13

Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment

Applicant Elos Medtech Pinol A/S

K-Number K241722

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PII 2024-09-13

T2Candida 1.1 Panel

Applicant T2biosystems, Inc.

K-Number K234063

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DZE 2024-09-13

DenQ Sub SLA Implant System

Applicant Denq

K-Number K240977

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QPB 2024-09-13

Vitruvian Liposaber

Applicant Black & Black Surgical, Inc.

K-Number K240188

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QZW 2024-09-13

Sleep Apnea Notification Feature (SANF)

Applicant Apple, Inc.

K-Number K240929

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MEH 2024-09-13

TheRay Collared and Collarless Femoral Stem

Applicant Nextstep Arthropedix

K-Number K241875

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QFQ 2024-09-13

Epitomee

Applicant Epitomee Medical , Ltd.

K-Number K240544

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OAP 2024-09-13

Revian Lyte (10011)

Applicant Revian, Inc.

K-Number K242441

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FRO 2024-09-13

Microdacyn Wound Care Solution

Applicant Sonoma Pharmaceuticals, Inc.

K-Number K233399

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SCR 2024-09-12

Hearing Aid Feature (HAF)

Applicant Apple, Inc.

K-Number DEN230081

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EBI 2024-09-12

Glidewell 3DP Denture Base Resin

Applicant Prismatik Dentalcraft, Inc.

K-Number K241493

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IYN 2024-09-12

MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K241432

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