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

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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KDN 2021-07-01

Cannula for Organ Perfusion

Applicant Bridge TO Life, Ltd.

K-Number K203262

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OWB 2021-07-01

ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9

Applicant Controlrad, Inc.

K-Number K211782

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MSD 2021-07-01

GlidePath Retro Long-Term Hemodialysis Catheter

Applicant C.R. Bard, Inc.

K-Number K203575

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CAF 2021-07-01

Pulmogine Vibrating Mesh Nebulizer

Applicant Hcmed Innovations Co., Ltd.

K-Number K202171

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KCT 2021-07-01

EZ-TRAXTM Persona Knee Containment Device

Applicant K1 Medical, LLC

K-Number K211007

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