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

OHS 2024-10-11

LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)

Applicant Dongguan Boyuan Intelligent Technology Co.,Ltd

K-Number K241857

View Details →

IPF 2024-10-10

eMVFit (MVF-10M)

Applicant Weero Co., Ltd.

K-Number K240992

View Details →

PHX 2024-10-10

Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid

Applicant Stryker Corporation (Tornier, S.A.S.)

K-Number K241491

View Details →

MAX 2024-10-10

KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System

Applicant Ctl Medical Corporation

K-Number K233947

View Details →

QIH 2024-10-10

AutoChamber

Applicant HeartLung Corporation

K-Number K240786

View Details →

GEX 2024-10-10

Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT

Applicant Quanta System Spa

K-Number K241092

View Details →

QLU 2024-10-10

INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number K240315

View Details →

ONB 2024-10-10

ProSeal™ In Line Pump Set (423850)

Applicant Epic Medical Pte. , Ltd.

K-Number K241735

View Details →

MSS 2024-10-10

EyeGility™ Inserter for Preloaded enVista IOLs

Applicant Bausch & Lomb, Incorporated

K-Number K242389

View Details →

FAJ 2024-10-10

Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance

Applicant Ambu A/S

K-Number K240848

View Details →

IZL 2024-10-10

uDR 380i Pro

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K242515

View Details →

QIH 2024-10-10

EchoMeasure

Applicant Icardio.Ai

K-Number K241430

View Details →

Page 511 of 2738

↑