Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

LLZ 2021-05-27

ZedView

Applicant Lexi Co., Ltd.

K-Number K200704

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NVM 2021-05-27

BIB Stent Placement Catheter

Applicant NuMED, Inc.

K-Number K211134

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KGO 2021-05-27

ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs

Applicant Careplus (M) Sdn Bhd

K-Number K202765

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GDW 2021-05-27

Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads

Applicant Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

K-Number K201639

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MAX 2021-05-26

Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K211258

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IYO 2021-05-26

Breast Volume Navigator (BVN) Model G-2000

Applicant Metritrack, Inc.

K-Number K211098

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DQY 2021-05-26

ViperCath XC Peripheral Exchange Catheter

Applicant Cardiovascular Systems, Inc.

K-Number K211251

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DZE 2021-05-26

Implacil Implant System

Applicant Implacil DE Bortoli Material Odontologico Ltda

K-Number K202832

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JOW 2021-05-26

PlasmaWave

Applicant Manamed, Inc.

K-Number K211253

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LPN 2021-05-26

OTE MPS 045 Multi-purpose Lens Care Solution

Applicant Ote North America, LLC

K-Number K210051

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BZH 2021-05-26

Peak flow meter

Applicant Shanghai Sonmol Medical Equipment Co., Ltd.

K-Number K203196

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LQR 2021-05-26

SpyGlass Discover Retrieval Basket

Applicant Boston Scientific Corporation

K-Number K203322

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