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

FXX 2021-07-02

Single-use Medical Face Mask

Applicant Conod Medical Co., Limited

K-Number K203591

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FYA 2021-07-02

Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown

Applicant Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.

K-Number K211422

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GEX 2021-07-02

The Alma Hybrid Laser System

Applicant Alma Lasers , Ltd.

K-Number K203441

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MEG 2021-07-02

Insulin Syringe, Insulin Syringe with Safety Retractable

Applicant Jiangsu Micsafe Medical Technology Co., Ltd.

K-Number K202570

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LOX 2021-07-02

Selethru(TM) NC PTCA Balloon Dilatation Catheter

Applicant Kossel Medtech (Suzhou) Co., Ltd.

K-Number K211393

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BZD 2021-07-02

Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask

Applicant Suzhou Yuyue Medical Technology Co., Ltd.

K-Number K203347

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FLE 2021-07-01

Bravo G4 Chamber Autoclave

Applicant Scican , Ltd.

K-Number K210326

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NRY 2021-07-01

Penumbra System (RED 68 Reperfusion Catheter)

Applicant Penumbra, Inc.

K-Number K211411

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LRK 2021-07-01

Snore Bandit

Applicant Snorebandit, LLC

K-Number K210910

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MUJ 2021-07-01

decimal Bolus

Applicant .Decimal, LLC

K-Number K211511

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LNH 2021-07-01

MAGNETOM Free.Max

Applicant Siemens Medical Solutions USA, Inc.

K-Number K210611

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OMP 2021-07-01

Avance Solo Negative Pressure Wound Therapy (NPWT) System

Applicant Molnlycke Health Care Us, LLC

K-Number K203369

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