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

PFO 2019-11-15

Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments

Applicant Cochlear Americas

K-Number K191921

View Details →

MYC 2019-11-15

DRSplus

Applicant Centervue S.P.A.

K-Number K192113

View Details →

HQF 2019-11-15

Ophthalmic Yag Laser System YC-200

Applicant Nidek Co., Ltd.

K-Number K192045

View Details →

PIF 2019-11-15

Gabriel Feeding Tube with Balloon, and EnFit Connector

Applicant Syncro Medical Innovations, Inc.

K-Number K191784

View Details →

QBK 2019-11-15

Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA

Applicant Immunalysis Corporation

K-Number K190397

View Details →

OWN 2019-11-15

SPY Portable Handheld Imaging (SPY-PHI) System

Applicant Novadaq Technologies Ulc. (Now A Part of Stryker)

K-Number K192174

View Details →

DZE 2019-11-15

EM SA Implant System

Applicant Hiossen, Inc.

K-Number K191201

View Details →

HSB 2019-11-14

EBA One Nailing System

Applicant Citieffe S.R.L.

K-Number K183666

View Details →

JWY 2019-11-14

MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)

Applicant Beckman Coulter, Inc.

K-Number K192355

View Details →

OWQ 2019-11-14

Reprocessed ViewFlex™ Xtra ICE Catheter

Applicant Sterilmed, Inc.

K-Number K190478

View Details →

DZE 2019-11-14

ST Internal Implant System

Applicant Megagen Implant Co., Ltd.

K-Number K192347

View Details →

FDX 2019-11-14

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes

Applicant Wilson-Cook Medical, Inc.

K-Number K192908

View Details →

Page 1776 of 2744

↑