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

PCC 2017-09-15

Cefaly Acute

Applicant Cefaly Technology

K-Number K171446

View Details →

ERL 2017-09-15

Stryker Consolidated Operating Room Equipment (CORE) 2 Console

Applicant Stryker Corporation

K-Number K171840

View Details →

OLO 2017-09-15

Mazor X

Applicant Mazor Robotics , Ltd.

K-Number K172522

View Details →

NBW 2017-09-15

iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)

Applicant Andon Health Co, Ltd.

K-Number K170231

View Details →

DQX 2017-09-15

Glidewire GT

Applicant Terumo Corporation

K-Number K170417

View Details →

NKB 2017-09-14

Range/Denali/Mesa Spinal System

Applicant K2m, Inc.

K-Number K171832

View Details →

KKX 2017-09-14

MediClear PreOp

Applicant Covalontechnologies, Inc.

K-Number K163556

View Details →

HWC 2017-09-14

BePOD® Foot Screws

Applicant Fournitures Hospitalieres Industrie

K-Number K163148

View Details →

IYN 2017-09-14

Clarius Ultrasound System

Applicant Clarius Mobile Health Corp.

K-Number K172385

View Details →

MWI 2017-09-14

Masimo Rad-97 and Accessories

Applicant Masimo Corporation

K-Number K170168

View Details →

HAW 2017-09-14

Fiagon Navigation System

Applicant Fiagon GmbH

K-Number K163209

View Details →

OLO 2017-09-14

VIPER PRIME navigated inserter

Applicant Medos International SARL

K-Number K170937

View Details →

Page 2254 of 2685

↑