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

MQV 2023-12-20

Tactoset® Injectable Bone Substitute

Applicant Anika Therapeutics, Inc.

K-Number K231968

View Details →

NGX 2023-12-20

EMS Neck Massager

Applicant Xiamen Comfier Technology Co., Ltd.

K-Number K233492

View Details →

GEI 2023-12-20

10THERMA

Applicant Tentech, Inc.

K-Number K232992

View Details →

DJG 2023-12-20

Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test

Applicant Chemtron Biotech, Inc.

K-Number K232736

View Details →

LAO 2023-12-20

ARK Methotrexate II Assay

Applicant Ark Diagnostics, Inc.

K-Number K232017

View Details →

OHT 2023-12-20

SmoothSkin Pure Adapt (SSG3)

Applicant Cyden Limited

K-Number K233782

View Details →

JKA 2023-12-20

BD Vacutainer® Serum Separator (SST) Blood Collection Tubes

Applicant Becton, Dickinson and Company

K-Number K230855

View Details →

LIT 2023-12-20

HP PTA Balloon Dilatation Catheter

Applicant Kossel Medtech (Suzhou) Co., Ltd.

K-Number K231402

View Details →

OOG 2023-12-20

United Orthopedic Knee Patient Specific Instrumentation

Applicant Enhatch, Inc.

K-Number K230850

View Details →

LLZ 2023-12-20

uOmnispace.MI

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K233176

View Details →

HIR 2023-12-20

Perifit Care+

Applicant X6 Innovations

K-Number K231780

View Details →

NHA 2023-12-20

INNO SLA Submerged Hybrid Ti-Base System

Applicant Cowellmedi Co., Ltd.

K-Number K231411

View Details →

Page 639 of 2685

↑