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

GCJ 2024-02-22

1688 4K Camera System with Advanced Imaging Modality

Applicant Stryker Endoscopy

K-Number K240174

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FMK 2024-02-22

NanoDrop Lancet

Applicant Drawbridge Health, Inc.

K-Number K223826

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KWQ 2024-02-22

Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System

Applicant Alphatec Spine, Inc.

K-Number K233640

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GEX 2024-02-22

MultiPulse HoPLUS

Applicant Asclepion Laser Technologies GmbH

K-Number K231876

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HIR 2024-02-22

Vaginal Tactile Ultrasound Imager

Applicant Advanced Tactile Imaging, Inc.

K-Number K231875

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NXC 2024-02-22

MESHEET

Applicant Dentis Co., Ltd.

K-Number K233544

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JAK 2024-02-22

Revolution Ascend Sliding

Applicant Ge Hangwei Medical Systems Co., Ltd.

K-Number K233749

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GEI 2024-02-22

Oligio X

Applicant Wontech Co., Ltd.

K-Number K240313

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MXA 2024-02-22

Vivatmo pro

Applicant Bosch Healthcare Solutions GmbH

K-Number K233775

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ITH 2024-02-22

Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac

Applicant Ergo-Flex Technologies, LLC

K-Number K214037

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QRY 2024-02-21

X-Guide Surgical Navigation System

Applicant X-Nav Technologies, LLC

K-Number K232148

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HQD 2024-02-21

Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)

Applicant Visionary Optics, LLC

K-Number K233325

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