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

EIH 2019-05-22

Dental Ceramic

Applicant Baot Biological Technology Co., Ltd.

K-Number K182350

View Details →

QEP 2019-05-22

cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit

Applicant Roche Molecular Systems, Inc.

K-Number K190433

View Details →

OLO 2019-05-22

Stealth-Midas MR8 System

Applicant Medtronic Powered Surgical Solutions

K-Number K183644

View Details →

NKG 2019-05-22

Connector System

Applicant Orthofix, Inc.

K-Number K190751

View Details →

IYE 2019-05-22

LIAC S

Applicant Sit Sordina Iort Technologies Spa

K-Number K182374

View Details →

QGY 2019-05-21

Smith & Nephew Tablet Application

Applicant Smith & Nephew

K-Number K190367

View Details →

HIH 2019-05-21

MAKO 7

Applicant Boston Scientific Corporation

K-Number K182975

View Details →

ITI 2019-05-21

Solax Powered Wheelchair

Applicant Dongguan Prestige Sporting Goods Co., Ltd.

K-Number K182576

View Details →

QAQ 2019-05-21

Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure

Applicant Edwards Lifeciences, LLC

K-Number K183646

View Details →

DZE 2019-05-21

ET IV SA Dental Implants

Applicant Hiossen, Inc.

K-Number K183242

View Details →

HWC 2019-05-21

IntraLock Lapidus System

Applicant Fusion Orthopedics, LLC

K-Number K182342

View Details →

GWO 2019-05-21

Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)

Applicant Kelyniam Global, Inc.

K-Number K182711

View Details →

Page 1896 of 2744

↑