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

JKA 2018-06-04

Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder

Applicant Zhejiang Kindly Medical Devices Co., Ltd.

K-Number K172763

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NXO 2018-06-04

BUHLMANN fCAL ELISA

Applicant Buhlmann Laboratories AG

K-Number K181012

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EZL 2018-06-04

Silicone Foley Catheter for single use

Applicant Changzhou Rongxin Medicine Minimal Invasion Technology

K-Number K172807

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DYB 2018-06-04

Check-Flo Performer Introducer Micropuncture Radial Artery Access Set

Applicant Cook Incorporated

K-Number K171609

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PCI 2018-06-01

PanNAT STEC Test

Applicant Micronics, Inc.

K-Number K173330

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CAW 2018-06-01

Oxygen Concentrator

Applicant Sysmed (China) Co., Ltd.

K-Number K172234

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KNT 2018-06-01

Bowel Management Device, Bowel Management Irrigation Set

Applicant Applied Medical Technology, Inc.

K-Number K180026

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PKL 2018-06-01

Single Use MultiClip Device

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K180325

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ONB 2018-06-01

NEOSHIELD

Applicant JMS North America Corporation

K-Number K172499

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DPS 2018-06-01

Kenz Cardico1211

Applicant Suzuken Co., Ltd.

K-Number K172068

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GXY 2018-06-01

Silverwear Silver Pro Garment Device

Applicant Media Plus, LLC

K-Number K171798

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NUC 2018-06-01

BioNude Lubricant

Applicant Good Clean Love, Inc.

K-Number K180136

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