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

QVE 2023-02-17

PMD-200

Applicant Medasense Biometrics , Ltd.

K-Number DEN210022

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FGB 2023-02-17

Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101

Applicant STERIS Corporation

K-Number K223466

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PKT 2023-02-17

EON

Applicant Dominion Aesthetic Technologies, Inc.

K-Number K222226

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OHT 2023-02-16

IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03

Applicant Morlaser Shenzhen Co., Ltd.

K-Number K223524

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LON 2023-02-16

VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin

Applicant bioMerieux, Inc.

K-Number K223478

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HAW 2023-02-16

Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System

Applicant Stryker Corporation

K-Number K212194

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JAK 2023-02-16

uCT ATLAS Astound with uWS-CT-Dual Energy Analysis

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K223028

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IYN 2023-02-16

Vivid S60N, Vivid S70N

Applicant Ge Medical System Ultrasound and Primary Care Diagnostics

K-Number K223832

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OBJ 2023-02-16

NUVISION NAV Ultrasound Catheter

Applicant Biosense Webster, Inc.

K-Number K223766

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HWC 2023-02-16

Bony Trauma Extremity System (BTES) Screw Range, NX Nail

Applicant Field Orthopaedics Pty, Ltd.

K-Number K230118

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LNH 2023-02-16

uMR 680

Applicant Shanghai United Imaging Intelligence Co., Ltd.

K-Number K222755

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FMI 2023-02-16

Sterile Aesthetic Cannula and Hypodermic Needle

Applicant Shanghai Kindly Enterprise Development Group Co., Ltd.

K-Number K223327

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