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

BZD 2022-01-10

iQ 2 Nasal Mask, Phantom 2 Nasal Mask

Applicant Sleepnet Corporation

K-Number K211274

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LKF 2022-01-10

DUMI ManipulatOR

Applicant The O R Company Pty, Ltd.

K-Number K212505

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DTR 2022-01-10

Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger

Applicant Qura S.R.L

K-Number K212688

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LZA 2022-01-09

Powder Free Nitrile Examination Gloves, Blue Chemotest

Applicant Careglove Global Sdn. Bhd.

K-Number K211666

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LZA 2022-01-09

Powder free nitrile examination glove- black, non sterile

Applicant Hong Seng Gloves Sdn Bhd

K-Number K212801

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KRA 2022-01-07

Agile Devices Angler Steerable, Deflectable Microcatheter

Applicant Agile Devices, Inc.

K-Number K211110

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HRS 2022-01-07

GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive

Applicant Gpc Medical Limited

K-Number K210198

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HTN 2022-01-07

Acumed Ankle Syndesmosis Repair System

Applicant Acumed, LLC

K-Number K212990

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HQD 2022-01-07

Custom Stable Rigid Gas Permeable Scleral Contact Lens

Applicant Valley Contax, Inc.

K-Number K213880

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OLO 2022-01-07

Vital Navigation System

Applicant Zimvie (Zimmer Biomet Spine, Inc.)

K-Number K213720

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QKM 2022-01-07

CELERITY HP Chemical Indicator

Applicant STERIS Corporation

K-Number K213262

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DZE 2022-01-07

CORE1 Implant System

Applicant Cybermed, Inc.

K-Number K210039

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