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

MAX 2019-09-16

AccelFix Lumbar Interbody Fusion Cage System

Applicant L&K BIOMED Co., Ltd.

K-Number K190708

View Details →

MUD 2019-09-16

Intra.Ox 2.0 Handheld Tissue Oximeter

Applicant Vioptix, Inc.

K-Number K191676

View Details →

DXN 2019-09-16

Full Automatic (NIBP) Blood Pressure Monitor

Applicant Health & Life Co., Ltd.

K-Number K190507

View Details →

LLZ 2019-09-16

SubtleMR

Applicant Subtle Medical, Inc.

K-Number K191688

View Details →

HRS 2019-09-16

AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws

Applicant Industrias Medicas Sampedro S.A.S

K-Number K191641

View Details →

NGT 2019-09-15

0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe

Applicant Medline Industries, Inc.

K-Number K191378

View Details →

LPL 2019-09-13

Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens

Applicant Visco Vision, Inc.

K-Number K183670

View Details →

EBF 2019-09-13

Infinix Universal Composite

Applicant Nobio , Ltd.

K-Number K182921

View Details →

CAF 2019-09-13

CapMedic

Applicant Cognita Labs, LLC

K-Number K183586

View Details →

OBI 2019-09-13

ACIST RXi System and Navvus II Catheter

Applicant Acist Medical Systems, Inc.

K-Number K190473

View Details →

MLR 2019-09-13

Sterilucent HC 80TT Hydrogen Peroxide Sterilizer

Applicant Sterilucent, Inc.

K-Number K190005

View Details →

CBK 2019-09-13

Bellavista

Applicant Imtmedical AG

K-Number K183364

View Details →

Page 1818 of 2744

↑