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

MAX 2024-10-07

EARP Interbody System

Applicant Retropsoas Technologies, LLC

K-Number K242457

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LPH 2024-10-07

EMPHASYS Acetabular Shell with RapiTite HA

Applicant Depuy Ireland UC

K-Number K242084

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HRS 2024-10-06

Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System

Applicant Stryker GmbH

K-Number K242445

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HRS 2024-10-04

BPS Wrist Fracture System

Applicant Orthonovis, Inc.

K-Number K242343

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GDW 2024-10-04

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)

Applicant Fengh Medical Co., Ltd.

K-Number K242679

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JOW 2024-10-04

UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFF

Applicant United Medical Resources, LLC

K-Number K241746

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OAB 2024-10-04

Electroporation System (N3000)

Applicant Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

K-Number K240376

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ONN 2024-10-04

QUADSENSE

Applicant Eventum Orthopaedics, Ltd.

K-Number K241298

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FBK 2024-10-04

Endoscopic Injection Needles

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K240675

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DXN 2024-10-04

Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131)

Applicant Shenzhen Finicare Co., Ltd.

K-Number K242721

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FGB 2024-10-04

Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2)

Applicant Shenzhen Besdata Technology Co., Ltd.

K-Number K240074

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GCJ 2024-10-04

Bladeless Trocar; Bladed Trocar; Hasson Trocar

Applicant Advamedix, GmbH

K-Number K241052

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