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

LLZ 2023-10-27

SwiftMR

Applicant Airs Medical, Inc.

K-Number K230854

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JFP 2023-10-27

i-STAT CG8+ cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K230300

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DXN 2023-10-27

Electronic Blood Pressure Monitor

Applicant Shenzhen Jumper Medical Equipment Co., Ltd.

K-Number K231310

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GEX 2023-10-27

DEKA AGAIN PRO family

Applicant El.En S.P.A.

K-Number K233090

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GWF 2023-10-27

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress

Applicant Inomed Medizintechnik GmbH

K-Number K233292

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OVE 2023-10-27

RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System

Applicant MiRus, LLC

K-Number K232348

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KNW 2023-10-27

EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast Biopsy Driver (DRENCORMR); EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT)

Applicant Senorx, Inc.

K-Number K233220

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QYJ 2023-10-27

BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge

Applicant Proedge Dental Products, Inc.

K-Number K232393

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QVI 2023-10-26

OGmend® Implant Enhancement System

Applicant Woven Orthopedic Technologies

K-Number K233223

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IYN 2023-10-26

TE Air Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K231685

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EZD 2023-10-26

Luja Coude (20108 Male CH18 - large packaging)

Applicant Coloplast Corp.

K-Number K233101

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IRP 2023-10-26

Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401)

Applicant Jiangsu Maxf Electric Appliance Co., Ltd.

K-Number K230500

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