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

PNR 2020-10-09

Medline ENfit OTC Feeding Syringe

Applicant Medline Industries, Inc.

K-Number K202285

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PFO 2020-10-09

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)

Applicant Med-El Elektromedizinische Geraete GmbH

K-Number K201983

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GDW 2020-10-09

AEON Endoscopic Stapler

Applicant Lexington Medical, Inc.

K-Number K201882

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DSA 2020-10-09

Multi-LinkTM X2 ECG Adapter and Leadwires

Applicant Vyaire Medical, Inc.

K-Number K200510

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NJM 2020-10-09

Luce Ceramic Bracket

Applicant Luce Castle Co., Ltd.

K-Number K201038

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JWH 2020-10-09

Klassic Knee System Tibial Inserts, PS-Max

Applicant Total Joint Orthopedics, Inc.

K-Number K202740

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GCJ 2020-10-08

Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality)

Applicant Stryker

K-Number K202592

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NKG 2020-10-08

LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System

Applicant L&K BIOMED Co., Ltd.

K-Number K200793

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HRS 2020-10-08

Piccolo Composite Proximal Tibia Plate System

Applicant CarboFix Orthopedics , Ltd.

K-Number K201917

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FPA 2020-10-08

Steripath Micro Blood Collection System

Applicant Magnolia Medical Technologies, Inc.

K-Number K200661

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NGX 2020-10-08

Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)

Applicant Guangzhou Longest Science & Technology Co., Ltd.

K-Number K201845

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HAW 2020-10-08

Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update

Applicant Brainlab AG

K-Number K192703

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