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

DYB 2023-11-30

14F iSLEEVE Introducer Set

Applicant Boston Scientific Corporation

K-Number K233503

View Details →

FMF 2023-11-30

Insulin Syringe

Applicant Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

K-Number K230061

View Details →

HIH 2023-11-30

Benesta Tissue Removal Device

Applicant Caldera Medical, Inc.

K-Number K233500

View Details →

KTT 2023-11-30

Auxein's DHS/DCS Plate System

Applicant Auxein Medical Private Limited

K-Number K221787

View Details →

DXQ 2023-11-29

Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2)

Applicant Shenzhen Plinma Technology Co. , Ltd.

K-Number K232772

View Details →

MAX 2023-11-29

Expandable Lumbar Fusion Cage (Type I,Type II)

Applicant Shanghai Reach Medical Instrument Co, Ltd.

K-Number K232069

View Details →

KRA 2023-11-29

XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)

Applicant Transit Scientific, LLC

K-Number K231821

View Details →

QYZ 2023-11-29

Mosie Baby Kit

Applicant Mosie Baby

K-Number K231203

View Details →

PEK 2023-11-29

Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate

Applicant Spinal Simplicity, LLC

K-Number K233527

View Details →

ODC 2023-11-29

Disposable Endoscope Valves System

Applicant Changzhou Endoclean Medical Device Co., Ltd.

K-Number K232244

View Details →

QJP 2023-11-29

CEREGLIDE 92 Intermediate Catheter

Applicant Cerenovus, Inc.

K-Number K230726

View Details →

HBE 2023-11-29

Surgify Halo

Applicant Surgify Medical OY

K-Number K232684

View Details →

Page 659 of 2685

↑