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

PSY 2024-06-24

Philips IntelliSite Pathology Solution 5.1

Applicant Philips Medical Systems Nederland B.V.

K-Number K233204

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HSN 2024-06-24

APEX 3D Total Ankle Replacement System

Applicant Paragon 28, Inc.

K-Number K240259

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EBW 2024-06-24

NLZ Built-In Motor System

Applicant Nakanishi, Inc.

K-Number K233288

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OHT 2024-06-24

Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)

Applicant Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd.

K-Number K241120

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GEI 2024-06-24

SILKRO

Applicant Hironic Co., Ltd.

K-Number K233123

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EIH 2024-06-24

Copran Zri

Applicant Whitepeaks Dental Solutions GmbH

K-Number K232952

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FGB 2024-06-24

Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aBox 2

Applicant Ambu A/S

K-Number K233630

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GEX 2024-06-24

Picosecond Nd:YAG Laser (PICOCAREMAJESTY)

Applicant Wontech Co., Ltd.

K-Number K241144

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FLL 2024-06-21

SteadyTemp

Applicant Steadysense GmbH

K-Number K233280

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KPE 2024-06-21

eZSURE Empty Fluid Container with ProSeal Injection Site

Applicant Epic Medical Pte. , Ltd.

K-Number K241442

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OWB 2024-06-21

See Factor CT3

Applicant Epica International, Inc.

K-Number K233230

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MQV 2024-06-21

Xerosyn

Applicant Xerothera, Inc.

K-Number K233259

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