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

MUJ 2022-05-17

Monaco RTP System

Applicant Elekta Solutions AB

K-Number K213787

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QAS 2022-05-17

Rapid PE Triage and Notification (PETN)

Applicant Ischemaview, Inc.

K-Number K220499

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IYN 2022-05-16

SONON Ultrasound Imaging System, Model: SONON300C

Applicant Healcerion Co., Ltd.

K-Number K211665

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FYC 2022-05-16

AAMI3 Isolation Gown

Applicant Hubei Xinxin Non-Woven Co., Ltd.

K-Number K213832

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LLZ 2022-05-16

Caas Qardia

Applicant Pie Medical Imaging BV

K-Number K212376

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LNH 2022-05-16

Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems

Applicant Philips Medical Systems Nederland B.V.

K-Number K213583

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FMG 2022-05-16

Clicky Cross

Applicant Yomura Technologies, Inc.

K-Number K210516

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MLR 2022-05-16

STERRAD NX with ALLClear Technology

Applicant Advanced Sterilization Products, Inc.

K-Number K220404

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OHT 2022-05-16

IPL HAIR REMOVAL HANDSET, Model: IPL-666

Applicant Shenzhen Junbobeauty Technology Co., Ltd.

K-Number K220669

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LZC 2022-05-14

Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs

Applicant Hainan Asther Medical Equipment Co., Ltd.

K-Number K220491

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FOZ 2022-05-14

Introcan Safety IV Catheter

Applicant B.Braun Medical, Inc.

K-Number K220626

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KWS 2022-05-13

SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid

Applicant Limacorporate

K-Number K213785

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