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

DQK 2023-09-07

CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)

Applicant Biosense Webster, Inc.

K-Number K231207

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JOW 2023-09-07

AeroDVx Arm System

Applicant Sun Scientific, Inc.

K-Number K222823

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EIH 2023-09-07

Gradual Dental Zirconia Blank

Applicant Liaoning Upcera Co., Ltd.

K-Number K231687

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EBF 2023-09-07

Signum opaque F

Applicant Kulzer, LLC

K-Number K230644

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DXN 2023-09-07

Arm Blood Pressure Monitor

Applicant Alicn Medical Shenzhen, Inc.

K-Number K230649

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FRG 2023-09-07

Steriking® LT-Blueline Pouches with Tyvek®

Applicant Wipak OY

K-Number K231999

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DYB 2023-09-07

Pounce Sheath

Applicant Surmodics,Inc.

K-Number K231828

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HIS 2023-09-07

SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT

Applicant Ttk Healthcare Limited

K-Number K230049

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MMX 2023-09-07

Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit

Applicant Argon Medical Devices, Inc.

K-Number K232443

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DXN 2023-09-07

Digital Blood Pressure Monitor WBP Series

Applicant Weony (Shenzhen) Technology Co., Ltd.

K-Number K231542

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GEI 2023-09-07

Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes

Applicant Jiangsu Bonss Medical Technology Co., Ltd.

K-Number K221743

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OHT 2023-09-07

IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9

Applicant Shenzhen Qianyu Technology Co., Ltd.

K-Number K231800

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