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

MBI 2023-05-23

Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath

Applicant Suzhou Endophix Co., Ltd.

K-Number K230874

View Details →

OMB 2023-05-23

Ceribell Status Epilepticus Monitor

Applicant Ceribell, Inc.

K-Number K223504

View Details →

DYB 2023-05-22

Kodiak™ Dual Port Coaxial Introducer Kit

Applicant Argon Medical Devices

K-Number K230631

View Details →

ODP 2023-05-22

Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)

Applicant Gbs Commonwealth Co., Ltd.

K-Number K230708

View Details →

MBI 2023-05-22

Integrity™ Bone Staple Fixation System

Applicant Anika Therapeutics, Inc.

K-Number K223860

View Details →

IYE 2023-05-22

TrueBeam, TrueBeam STx, Edge, VitalBeam

Applicant Varian Medical Systems, Inc.

K-Number K223839

View Details →

EZD 2023-05-22

PVC Hydrophilic Urethral Catheter

Applicant Well Lead Medical Co., Ltd.

K-Number K220722

View Details →

GEX 2023-05-22

HELIOS 785 Pico

Applicant Laseroptek Co., Ltd.

K-Number K230373

View Details →

LHI 2023-05-22

MixJect® Transfer Device

Applicant West Pharma. Services IL, Ltd.

K-Number K230464

View Details →

NUH 2023-05-22

TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)

Applicant Jiangxi Royall Smart Technology Co., Ltd.

K-Number K230443

View Details →

KLE 2023-05-22

Hi-Bond Universal

Applicant Mediclus Co., Ltd.

K-Number K230465

View Details →

GEX 2023-05-22

Laser Thermal Therapy Kit

Applicant Elesta S.P.A

K-Number K230460

View Details →

Page 882 of 2738

↑