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

MQL 2022-06-16

Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])

Applicant Donnevie Medical Technology (Shanghai) Co. , Ltd.

K-Number K212426

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NHA 2022-06-16

Straumann TLX Variobase C

Applicant Institut Straumann AG

K-Number K220878

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NXC 2022-06-16

Custom-made Invisible Aligners

Applicant Zhejiang Yinchili Medical Technology Co., Ltd.

K-Number K203624

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LLZ 2022-06-15

SurgiCase Viewer

Applicant Materialise NV

K-Number K213684

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DXN 2022-06-15

QardioArm 2

Applicant Qardio, Inc.

K-Number K220106

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GYB 2022-06-15

EEG-acp

Applicant Somnomedics GmbH

K-Number K212325

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FMI 2022-06-15

MEDOJECT fine Pen Needles

Applicant Chirana T. Injecta

K-Number K220614

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IYE 2022-06-15

ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)

Applicant Varian Medical Systems, Inc.

K-Number K221448

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LOJ 2022-06-15

VITROS AFP

Applicant Ortho Clinical Diagnostics

K-Number K213626

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KLE 2022-06-15

Dia-X Bond Universal

Applicant DiaDent Group International

K-Number K220804

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LRK 2022-06-15

ZQuiet Advance

Applicant Sleeping Well, LLC

K-Number K213088

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PLV 2022-06-14

Yomi Robotic System with YomiPlan Go

Applicant Neocis, Inc.

K-Number K211466

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