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

PKL 2020-10-19

Single Use Rotatable and Repositionable Hemoclip

Applicant Anrei Medical (Hangzhou) Co., Ltd.

K-Number K201771

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OWY 2020-10-19

TAPESTRY Biointegrative Implant

Applicant Embody, Inc.

K-Number K201572

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FRO 2020-10-19

anti-bacterial bandage

Applicant Planet (Suzhou) Medical Products Co., Ltd.

K-Number K200821

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NKB 2020-10-19

CD Horizon Spinal System

Applicant Medtronic

K-Number K202771

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PGY 2020-10-19

4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+

Applicant Shenzhen Beacon Display Technology Co., Ltd.

K-Number K202374

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NUH 2020-10-19

Transcutaneous Electronic Nerve Stimulator

Applicant Shenzhen Kentro Medical Electronics Co., Ltd.

K-Number K200237

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MAX 2020-10-19

Zavation IBF System

Applicant Zavation Medical Products, LLC

K-Number K200084

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PLV 2020-10-19

Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)

Applicant Neocis, Inc.

K-Number K202100

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DTX 2020-10-16

Quantum Ventilation Module

Applicant Spectrum Medical , Ltd.

K-Number K202733

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DQY 2020-10-16

Selectra 3D Outer Guiding Catheters

Applicant Biotronik, Inc.

K-Number K193474

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GEI 2020-10-16

Medline Smoke Evacuation Pencil

Applicant Medline Industires, Inc.

K-Number K201129

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LYZ 2020-10-16

Disposable Vinyl Glove

Applicant Better Health Medical Products Co., Ltd.

K-Number K202010

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