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

OAS 2022-03-02

Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph

Applicant Fona S.R.L

K-Number K213579

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KPL 2022-03-02

Bio Fluff System

Applicant Gnali Bocia S.R.L.

K-Number K201861

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FZP 2022-03-02

angioLOCK Polymer Ligating Clip

Applicant A2 Medical Systems, LLC

K-Number K220006

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FRN 2022-03-01

Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo

Applicant Fresenius Kabi AG

K-Number K210073

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KRD 2022-03-01

Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS

Applicant Artventive Medical Group, Inc.

K-Number K212057

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LPH 2022-03-01

Restoration® Modular Hip System

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K-Number K212187

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DXN 2022-03-01

Wrist-type Fully Automatic Digital Blood Pressure Monitor

Applicant Joytech Healthcare Co. , Ltd.

K-Number K213189

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KGO 2022-03-01

Sterile Latex Surgical Gloves Powder Free

Applicant Amazing Rubber Products Pvt, Ltd.

K-Number K212596

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QBS 2022-03-01

BoneView

Applicant Gleamer

K-Number K212365

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MCW 2022-03-01

DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System

Applicant Cardiovascular Systems, Inc.

K-Number K220109

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MEG 2022-03-01

Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles

Applicant Shinva Ande Healthcare Apparatus Co., Ltd.

K-Number K211484

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DZE 2022-03-01

LOTA SLA Dental Implant System and LOTA HA Dental Implant System

Applicant Kj Meditech Co., Ltd.

K-Number K202046

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