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

KNT 2021-09-23

Standard Bougie, 38 Fr. and Hand Pump

Applicant Standard Bariatrics

K-Number K212728

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ONB 2021-09-23

OnGuard2 Chemfort Closed Administration (CADM)

Applicant Simplivia Healthcare , Ltd.

K-Number K210707

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JWH 2021-09-23

Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)

Applicant Conformis, Inc.

K-Number K212411

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ODP 2021-09-23

Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage

Applicant Medynus, Inc.

K-Number K212792

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LLZ 2021-09-23

JiveX (Model Number / Release: 5.3)

Applicant Visus Health IT GmbH

K-Number K212321

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HIS 2021-09-23

One Touch Spiral Condom

Applicant Thai Nippon Rubber Industry Public Company Limited.

K-Number K210294

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DXQ 2021-09-23

Reusable NIBP Cuff

Applicant Shenzhen Coreray Technology Co., Ltd.

K-Number K211747

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FMI 2021-09-23

Sterile Hypodermic Needles for Single Use

Applicant Zhejiang Kangkang Medical-Devices Co., Ltd.

K-Number K210232

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HWC 2021-09-23

Nexta PEEK Hammertoe Correction System

Applicant Nextremity Solutions, Inc.

K-Number K211996

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NFO 2021-09-23

ZIIP+ Device

Applicant Ziip, Inc.

K-Number K212342

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LAZ 2021-09-23

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)

Applicant Changzhou Universal Medical Equipment Co., Ltd.

K-Number K211667

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DZE 2021-09-23

ABC Dental Implant System

Applicant Abracadabra Implants , Ltd.

K-Number K202092

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