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

LNH 2022-04-05

Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K220335

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FMK 2022-04-05

Accu-Chek Safe-T-Pro Uno Lancing Device

Applicant Roche Diabetes Care, Inc.

K-Number K220364

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IYN 2022-04-05

HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K220043

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PBQ 2022-04-05

Apyx

Applicant Escala Medical

K-Number K213783

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MUJ 2022-04-05

MRCAT Head & Neck

Applicant Philips OY

K-Number K214081

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FLL 2022-04-05

Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)

Applicant Taidoc Technology Corporation

K-Number K200946

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HRS 2022-04-05

DRPx Locking Distal Radius Plate System

Applicant Orthopaedic Implant Company

K-Number K212601

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QEZ 2022-04-04

AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System

Applicant AngioDynamics, Inc.

K-Number K213388

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EHD 2022-04-04

ERI Handheld Dental X-ray System (Model AG100)

Applicant Energy Resources International Co., Ltd. Hsinchu Branch

K-Number K213282

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QIH 2022-04-04

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System

Applicant Ever Fortune.Ai, Co., Ltd.

K-Number K212624

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NKB 2022-04-04

Invictus® Spinal Fixation System

Applicant Alphatec Spine, Inc.

K-Number K214006

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DZE 2022-04-04

TRATE Dental Implant System

Applicant Trate AG

K-Number K220022

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