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

LPN 2020-05-26

Aqua Naina Sterile Saline Solution

Applicant Chemtex USA, Inc.

K-Number K193441

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NHJ 2020-05-26

Maximus System

Applicant Hill-Rom Services Pte, Ltd.

K-Number K200988

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GWM 2020-05-26

Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level

Applicant Medtronic, Inc.

K-Number K201118

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KPR 2020-05-26

UNIEXPERT 2 PLUS

Applicant Adani

K-Number K200944

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NKB 2020-05-22

VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0

Applicant Icotec AG

K-Number K193423

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QKZ 2020-05-22

NaviCam Capsule Endoscope System with NaviCam Stomach Capsule

Applicant Anx Robotica, Inc.

K-Number DEN190037

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LJT 2020-05-22

SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports

Applicant AngioDynamics, Inc.

K-Number K190559

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OBJ 2020-05-22

Reconnaissance PV .018 OTW Digital IVUS Catheter

Applicant Philips Image Guided Therapy Corporation

K-Number K200410

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FYA 2020-05-22

Surgical Gown

Applicant Shandong Kangli Medical Equipment Technology Co., Ltd.

K-Number K192560

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CCK 2020-05-22

CO2 Sidestream Module

Applicant Beijing Kingst Commercial & Trade Co., Ltd.

K-Number K192488

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NUC 2020-05-22

Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming

Applicant CC Wellness, LLC

K-Number K200457

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FED 2020-05-22

Kalera Vacuum Aspiration Catheter (K-VAC)

Applicant Kalera Medical, Inc.

K-Number K200419

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