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

QRY 2022-11-04

Yomi Robotic System

Applicant Neocis, Inc.

K-Number K222049

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FMI 2022-11-04

Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle

Applicant Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

K-Number K222124

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MZP 2022-11-04

cobas HCV

Applicant Roche Molecular Systems, Inc.

K-Number K221007

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LPH 2022-11-04

United U2 femoral head, 22mm delta ceramic head

Applicant United Orthopedic Corporation

K-Number K221675

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NBW 2022-11-04

BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System

Applicant Apex BioTechnology Corp.

K-Number K220421

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HRS 2022-11-04

Humerus & Ulna System

Applicant Auxein Medical Private Limited

K-Number K213108

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FMF 2022-11-04

Medwell Technology Ltd Syringes, various sizes

Applicant Medwell Technology, Ltd.

K-Number K212764

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OHS 2022-11-03

Led Mask Platinum Md

Applicant Cellreturn Co., Ltd.

K-Number K222377

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GEI 2022-11-03

truSculpt iD

Applicant Cutera, Inc.

K-Number K223110

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FMK 2022-11-03

Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler

Applicant Owen Mumford, Ltd.

K-Number K222168

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FMF 2022-11-03

Insulin Syringes without needle

Applicant Berpu Medical Technology Co., Ltd.

K-Number K221045

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HQB 2022-11-03

Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers

Applicant Vortex Surgical, Inc.

K-Number K220263

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