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

JOP 2024-07-19

VasoGuard (V10, V8, V6, V4, V2)

Applicant Corvascular Diagnostics, LLC

K-Number K233976

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EBG 2024-07-19

Premium Teeth Resin

Applicant Formlabs Ohio, Inc.

K-Number K240538

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FRO 2024-07-18

Field Shield Wound Dressing

Applicant Kericure, Inc.

K-Number K212521

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PCC 2024-07-18

CEFALY Connected - OTC, CEFALY Connected - Rx

Applicant Cefaly Technology

K-Number K234029

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GWM 2024-07-18

B4C System - Addition of new sensor model (BcSs-PICNIW-2000)

Applicant Braincare Desenvolvimento E Inovação Tecnológica S.A.

K-Number K240821

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LBH 2024-07-18

Papacarie Duo

Applicant Elevate Oral Care

K-Number K233768

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PHX 2024-07-18

Equinoxe® Central Screw Baseplate System

Applicant Exactech, Inc.

K-Number K233482

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DTN 2024-07-18

Quantum Perfusion Hybrid System

Applicant Spectrum Medical S.R.L.

K-Number K241206

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DZI 2024-07-18

Surgical Drive System (Model: ES70, ES90, E8)

Applicant Guangdong Jinme Medical Technology Co., Ltd.

K-Number K240340

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JTN 2024-07-18

HardyDisk AST Cefiderocol 30µg (FDC30)

Applicant Hardy Diagnostics

K-Number K241060

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FZP 2024-07-18

SOLID CLIP Single Use Clip Applier

Applicant Medscope Biotech Co., Ltd.

K-Number K221495

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QOF 2024-07-18

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

Applicant Hologic, Inc.

K-Number K241240

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