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

FRG 2018-06-05

SIGMA Sterilization Pouch and Roll

Applicant Sigma Medical Supplies Corp.

K-Number K180661

View Details →

NFO 2018-06-05

TAMA BEMS device

Applicant Tama Research Corporation

K-Number K173093

View Details →

OLP 2018-06-04

reVive Light Therapy LED Cleansing System

Applicant Led Technologies, Inc.

K-Number K180447

View Details →

HWC 2018-06-04

VariAx 2 System

Applicant Stryker GmbH

K-Number K180500

View Details →

NEU 2018-06-04

SmartClip Soft Tissue Marker

Applicant Elucent Medical, Inc.

K-Number K180640

View Details →

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

View Details →

NXO 2018-06-04

BUHLMANN fCAL ELISA

Applicant Buhlmann Laboratories AG

K-Number K181012

View Details →

EZL 2018-06-04

Silicone Foley Catheter for single use

Applicant Changzhou Rongxin Medicine Minimal Invasion Technology

K-Number K172807

View Details →

DYB 2018-06-04

Check-Flo Performer Introducer Micropuncture Radial Artery Access Set

Applicant Cook Incorporated

K-Number K171609

View Details →

PCI 2018-06-01

PanNAT STEC Test

Applicant Micronics, Inc.

K-Number K173330

View Details →

CAW 2018-06-01

Oxygen Concentrator

Applicant Sysmed (China) Co., Ltd.

K-Number K172234

View Details →

KNT 2018-06-01

Bowel Management Device, Bowel Management Irrigation Set

Applicant Applied Medical Technology, Inc.

K-Number K180026

View Details →

Page 2121 of 2738

↑