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

ITI 2018-12-11

Invacare TDX SP2-HD with Captain's Seat

Applicant Invacare Corporation

K-Number K182946

View Details →

LZO 2018-12-11

BI-MENTUM dual mobility system

Applicant Serf

K-Number K181744

View Details →

GEX 2018-12-11

Magma Spark Pro (Magma Spark Plus, Alpha)

Applicant Formatk Systems , Ltd.

K-Number K183307

View Details →

LPL 2018-12-11

Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker

Applicant CooperVision, Inc.

K-Number K181920

View Details →

FRG 2018-12-11

Cardinal Health Sterilization Wrap

Applicant Cardinal Health200, LLC

K-Number K181174

View Details →

LPL 2018-12-11

Precision1

Applicant Alcon Laboratories, Inc.

K-Number K182902

View Details →

NKB 2018-12-11

OpenLoc-L Spinal Fixation System

Applicant L&K BIOMED Co., Ltd.

K-Number K183168

View Details →

PWE 2018-12-10

reSET-O

Applicant Pear Therapeutics, Inc.

K-Number K173681

View Details →

PHX 2018-12-10

Glenoid Polyaxial Non-locking Screws

Applicant Medacta International S.A.

K-Number K181826

View Details →

CAF 2018-12-10

Hailie Sensor

Applicant Adherium (Nz), Ltd.

K-Number K181405

View Details →

HKI 2018-12-10

LipiScan Dynamic Meibomian Imager

Applicant Tearscience, Inc.

K-Number K182506

View Details →

GEX 2018-12-10

SabreLine and SabreGuard Laser Fibers

Applicant Coloplast Corp.

K-Number K182831

View Details →

Page 1931 of 2685

↑