Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

JOH 2021-08-05

TRACOE vario

Applicant Tracoe Medical GmbH

K-Number K203362

View Details →

LZO 2021-08-05

EMPHASYS Femoral Stems

Applicant Depuy Ireland UC

K-Number K211657

View Details →

LZA 2021-08-05

Nitrile Patient Examination Gloves

Applicant Zhangjiagang Huayuan Protective Equipment Co., Ltd.

K-Number K211434

View Details →

QJP 2021-08-05

SelectFlex Neurovascular Access System Family

Applicant Q'Apel Medical, Inc.

K-Number K211893

View Details →

NWM 2021-08-05

ARK Lacosamide Assay

Applicant Ark Diagnostics, Inc.

K-Number K201089

View Details →

DQK 2021-08-05

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K-Number K210680

View Details →

MAX 2021-08-05

Lateral Spine Truss System (LSTS) Interbody Fusion Device

Applicant 4Web Medical, Inc.

K-Number K211388

View Details →

LNH 2021-08-04

Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K212056

View Details →

LFL 2021-08-04

Ultrasonic Bipolar Generator USG-410 with accessories

Applicant Olympus Medical Systems Corporation

K-Number K211838

View Details →

DQD 2021-08-04

PrevisEA Device

Applicant Entac Medical, Inc.

K-Number K211068

View Details →

IRP 2021-08-04

V12 PRO

Applicant Slk Medical GmbH

K-Number K210913

View Details →

NHA 2021-08-04

DESS Dental Smart Solutions

Applicant Terrats Medical SL

K-Number K203464

View Details →

Page 1288 of 2685

↑