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

FMT 2025-01-17

Babyroo TN300

Applicant Draeger Medical Systems, Inc.

K-Number K243606

View Details →

HGP 2025-01-17

Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)

Applicant Neoventa Medical AB

K-Number K243291

View Details →

NHA 2025-01-17

Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)

Applicant Smart Denture Conversions, LLC

K-Number K242064

View Details →

QJP 2025-01-17

VersaD Delivery Catheter

Applicant Unity Medical, Inc.

K-Number K242051

View Details →

DQK 2025-01-17

Affera Integrated Mapping System

Applicant Medtronic, Inc.

K-Number K243892

View Details →

JOJ 2025-01-17

Type 5 Integrating Indicator for Steam (CSPN-15)

Applicant True Indicating, LLC

K-Number K242860

View Details →

LNH 2025-01-17

Prenuvo Body Composition

Applicant Prenuvo

K-Number K242825

View Details →

QBC 2025-01-16

Cala kIQ

Applicant Cala Health, Inc.

K-Number K243848

View Details →

NFO 2025-01-16

Medi Lift Mask

Applicant Ya-Man, Ltd.

K-Number K244048

View Details →

FRN 2025-01-16

Remunity 2.0 Pump for Remodulin (treprostinil) Injection

Applicant Deka Research and Development Corp.

K-Number K241736

View Details →

NXC 2025-01-16

Pearl Clear Aligner

Applicant Pearl Digital, Inc.

K-Number K242715

View Details →

DPS 2025-01-16

CloudHRV™ System (100-01-001)

Applicant Inmedix, Inc.

K-Number K241217

View Details →

Page 437 of 2738

↑