Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

KOB 2024-11-01

AMT Low-Profile Suprapubic Catheter & Drainage Set

Applicant Applied Medical Technology, Inc.

K-Number K240514

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DRF 2024-11-01

EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter

Applicant Boston Scientific Corporation

K-Number K240366

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DXF 2024-11-01

VersaCross™ RF Wire

Applicant Baylis Medical Company

K-Number K242076

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HTN 2024-11-01

EXPERT - Flexible Joint Fixation System

Applicant GM Dos Reis Industria e Comercio Ltda.

K-Number K242311

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KPR 2024-11-01

uDR 780i

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K241068

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OAP 2024-11-01

Breo Laser Hair Growth Comb (Scalp 3L)

Applicant Shenzhen Breo Technology Co., Ltd.

K-Number K242620

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GAG 2024-11-01

Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)

Applicant Covidien (Part of Medtronic)

K-Number K240881

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JWJ 2024-11-01

Total Wrist Arthroplasty System (TWA)

Applicant Skeletal Dynamics, Inc.

K-Number K243381

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GEX 2024-11-01

ORTIV (ORTIV-BL, ORTIV-WH)

Applicant Mvitro Co., Ltd.

K-Number K241646

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JKA 2024-11-01

BD Vacutainer® One Use Holder

Applicant Becton, Dickinson and Company

K-Number K242320

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FED 2024-11-01

Over-tube (TR-1108A)

Applicant Fujifilm Corporation

K-Number K243091

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KTT 2024-11-01

Monkey Bars Pin to Bar External Fixation System

Applicant Paragon 28, Inc.

K-Number K242452

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