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

GEX 2022-10-12

Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)

Applicant Fotona D.O.O.

K-Number K221712

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ISA 2022-10-12

OW100S (model OW100S-US)

Applicant Tissue Regeneration Technologies, LLC Dba AS Softwave Trt

K-Number K213120

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FYC 2022-10-11

AAMI4 Isolation Gown

Applicant Hubei Xinxin Non-Woven Co., Ltd.

K-Number K214116

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GEI 2022-10-11

Apyx One Console

Applicant Apyx Medical Corporation

K-Number K221830

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FXX 2022-10-11

Surgical Mask

Applicant Luoyang Sunmed Devices Co., Ltd.

K-Number K222335

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IYN 2022-10-11

SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)

Applicant Bionet Co., Ltd.

K-Number K220169

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GCJ 2022-10-11

Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control

Applicant Stryker Endoscopy

K-Number K222079

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OHT 2022-10-11

IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439

Applicant Hunan Guangye Biotechnology Co., Ltd.

K-Number K222432

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HQF 2022-10-11

ECHO Photocoagulator

Applicant Norlase

K-Number K222157

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QJP 2022-10-11

Branchor Balloon Guide Catheter

Applicant Asahi Intecc Co., Ltd.

K-Number K221951

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EBF 2022-10-11

Renamel® Microhybrid ;Renamel® Flowable Microhybrid

Applicant Cosmedent, Inc.

K-Number K222435

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FMF 2022-10-11

Sol-M Luer Lock Syringe

Applicant Sol-Millennium Medical, Inc.

K-Number K222744

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