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

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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QKQ 2022-03-01

Dynamyx Digital Pathology Software

Applicant Inspirata, Inc.

K-Number K210811

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FMF 2022-03-01

Sure-Fine Insulin Syringes

Applicant Shina Med Corporation

K-Number K210848

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MXK 2022-03-01

MYAH

Applicant Visia Imaging S.R.L.

K-Number K211868

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FRN 2022-03-01

Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable

Applicant Fresenius Kabi AG

K-Number K210074

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OUR 2022-03-01

Blue Topaz Sacroiliac Screw System

Applicant Osseus Fusion Systems, LLC

K-Number K213590

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