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

HCG 2021-07-07

Axium Detachable Coil; Axium Prime Detachable Coil

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K203432

View Details →

GEH 2021-07-07

Hydrozid

Applicant Medilink A/S

K-Number K201740

View Details →

FXX 2021-07-07

Surgical Mask

Applicant Changzhou Holymed Products Co., Ltd.

K-Number K210524

View Details →

MBI 2021-07-07

Grappler Suture Anchor System

Applicant Paragon 28, Inc.

K-Number K211002

View Details →

DQY 2021-07-07

Arterial Catheter

Applicant Haolang Medical USA Corporation

K-Number K201726

View Details →

FYA 2021-07-07

Surgical Gowns

Applicant Jiangsu Province Jianerkang Medical Dressing Co., Ltd.

K-Number K210215

View Details →

LLZ 2021-07-07

ONE Planner Hip

Applicant Orthosoft D/B/A Zimmer Cas

K-Number K210653

View Details →

LNH 2021-07-07

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

Applicant Hyperfine, Inc.

K-Number K211818

View Details →

FLL 2021-07-07

Infrared Forehead Thermometer

Applicant Shenzhen Combei Technology Co., Ltd.

K-Number K202741

View Details →

MAX 2021-07-07

Pantheon IBFD

Applicant Pantheon Spinal

K-Number K203003

View Details →

NXC 2021-07-06

TRIOCLEAR System

Applicant Perfection Aligner System Hong Kong Limited

K-Number K193622

View Details →

DYB 2021-07-06

SafeCross Transseptal Puncture and Introducer (TSP/I) System

Applicant East End Medical I, LLC

K-Number K203459

View Details →

Page 1312 of 2685

↑