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

ODP 2021-09-30

ORIO-Ti Intervertebral Body Fusion Cage System

Applicant Spinecraft, LLC

K-Number K211935

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FMI 2021-09-30

SteriCap Mini Needle and Standard Needles

Applicant Ocuject, LLC

K-Number K212805

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PNR 2021-09-30

Enteral Pump Syringe

Applicant Jiangsu Caina Medical Co.,Ltd

K-Number K211593

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DXJ 2021-09-30

Philips IntelliVue GuardianSoftware (Rev. E.0X)

Applicant Philips Medizin Systeme Boeblingen GmbH

K-Number K212208

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NFO 2021-09-29

TheraFace Microcurrent

Applicant Theragun, Inc.

K-Number K212238

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LZA 2021-09-29

Disposable Nitrile Gloves

Applicant Jiangsu Jinke Protective Equipment Co., Ltd.

K-Number K211781

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MEG 2021-09-29

DR Safety Syringe, Sterile Hypodermic needle for Single use

Applicant Zhuhai DR Medical Instruments Co., Ltd.

K-Number K212226

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BSP 2021-09-29

RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles

Applicant Myco Medical Supplies, Inc.

K-Number K203668

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OCX 2021-09-29

ENDOtube

Applicant Nissha Medical Technologies Sas

K-Number K203350

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GEI 2021-09-29

LAP-iX

Applicant Sejong Medical Co., Ltd.

K-Number K200639

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NXC 2021-09-29

Inman Digital Clear Aligners

Applicant Inman Orthodontic Laboratories, Inc.

K-Number K210763

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LLZ 2021-09-29

ImmersiveTouch

Applicant Immersivetouch, Inc.

K-Number K210726

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