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

EBF 2023-11-01

TERA HARZ II

Applicant Graphy, Inc.

K-Number K233502

View Details →

QEW 2023-11-01

Aventus Thrombectomy System

Applicant Inquis Medical

K-Number K232730

View Details →

GCJ 2023-11-01

Inzii Ripstop Redeployable Retrieval System

Applicant Applied Medical Resources Corporation

K-Number K232880

View Details →

OQB 2023-11-01

OptiMesh Multiplanar Expandable Interbody Fusion System

Applicant Spineology, Inc.

K-Number K230927

View Details →

DTZ 2023-11-01

CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)

Applicant Chalice Medical , Ltd.

K-Number K231414

View Details →

MXD 2023-10-31

LINQ II™ Insertable Cardiac Monitor (LNQ22)

Applicant Medtronic, Inc.

K-Number K233320

View Details →

JWY 2023-10-31

Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml

Applicant Thermo Fisher Scientific

K-Number K232310

View Details →

DQY 2023-10-31

091 Balloon Guide Catheter

Applicant Eosolutions, Corp.

K-Number K231629

View Details →

DRA 2023-10-31

FlexCath Contour™ Steerable Sheath

Applicant Medtronic, Inc.

K-Number K232321

View Details →

KNS 2023-10-31

Speedboat Flush SB1 Instrument

Applicant Creo Medical, Ltd.

K-Number K230328

View Details →

DZE 2023-10-31

Neodent Implant System - GM Zygomatic Implant System

Applicant JJGC Indústria e Comércio de Materiais Dentários S.A.

K-Number K232099

View Details →

KWQ 2023-10-31

VICTORY™ Lumbar Plate System

Applicant Globus Medical, Inc.

K-Number K232318

View Details →

Page 752 of 2738

↑