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

KPS 2024-07-26

Symbia SPECT and SPECT/CT Systems

Applicant Siemens Healthineers

K-Number K241898

View Details →

HIH 2024-07-26

ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)

Applicant Origyn Medical Technology (Hangzhou) Co., Ltd.

K-Number K240401

View Details →

OLO 2024-07-26

Spine Navigation System

Applicant Medivis, Inc.

K-Number K233725

View Details →

EZD 2024-07-26

Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)

Applicant Coloplast

K-Number K241028

View Details →

KPR 2024-07-26

EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)

Applicant DRTECH Corporation

K-Number K233530

View Details →

QMA 2024-07-26

Cell-Free DNA BCT

Applicant Streck, Inc.

K-Number K231776

View Details →

MNR 2024-07-26

“LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)

Applicant Largan Medical Co., Ltd.

K-Number K233501

View Details →

MMI 2024-07-25

Atellica® IM High-Sensitivity Troponin I (TnIH)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K241165

View Details →

OLO 2024-07-25

Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories

Applicant Stryker Leibinger GmbH & Co KG

K-Number K241171

View Details →

FGB 2024-07-25

KARL STORZ Fiber Telescopes for Urology

Applicant Karl Storz SE & CO. KG

K-Number K233372

View Details →

PLV 2024-07-25

Navident

Applicant Claronav, Inc.

K-Number K233563

View Details →

GCJ 2024-07-25

Arthrex Synergy Vision Endoscopic Imaging System

Applicant Arthrex, Inc.

K-Number K241361

View Details →

Page 565 of 2738

↑