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

QLQ 2022-08-19

prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments

Applicant Centinel Spine, LLC

K-Number K221848

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PEK 2022-08-19

Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5

Applicant Spinal Simplicity, LLC

K-Number K221023

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FLE 2022-08-19

Lexa PLUS RIS-311

Applicant W&H Sterilization S.R.L.

K-Number K213758

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ODP 2022-08-19

uCerv Flux-C 3D Porous Titanium Cervical Interbody

Applicant Ulrich Medical USA

K-Number K220696

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JDR 2022-08-19

DynaClip® Bone Staple

Applicant MedShape, Inc.

K-Number K220812

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LHI 2022-08-19

Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices

Applicant Advcare Medical

K-Number K212525

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PCH 2022-08-19

BD MAX Enteric Parasite Panel

Applicant Becton, Dickinson and Company

K-Number K220193

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ODG 2022-08-19

FUJIFILM Ultrasonic Endoscope EG-740UT

Applicant Fujifilm Corporation

K-Number K221238

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FBK 2022-08-19

Disposable Endoscope Injection Needle

Applicant Yangzhou Fartley Medical Instrument Technology Co., Ltd.

K-Number K220292

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QJI 2022-08-19

SmartAdjust(TM) technology

Applicant Insulet Corporation

K-Number K220394

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DQX 2022-08-19

Stent Positioning Assistance System (SPAS)

Applicant Seven Sons , Ltd.

K-Number K221917

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NKB 2022-08-19

Cortera Spinal Fixation System

Applicant Surgalign Spine Technologies

K-Number K221403

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