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

NXC 2021-04-23

3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)

Applicant 3M Company, Unitek Orthodontic Products

K-Number K211190

View Details →

KPS 2021-04-23

Cartesion Prime (PCD-1000A/3) V10.8

Applicant Canon Medical Systems Corporation

K-Number K203314

View Details →

PPN 2021-04-22

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter

Applicant Shockwave Medical, Inc.

K-Number K203365

View Details →

DZE 2021-04-22

IDCAM Dental Implants

Applicant Implants Diffusion International

K-Number K200329

View Details →

HGX 2021-04-22

Mya Joy PLUS Breast Pump

Applicant Ameda, Inc.

K-Number K203570

View Details →

LXC 2021-04-22

MY01 Continuous Compartmental Pressure Monitor

Applicant MY01, Inc.

K-Number K210525

View Details →

JOW 2021-04-22

DVT-PRO

Applicant Daesung Maref Co., Ltd.

K-Number K203353

View Details →

BZR 2021-04-22

Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50

Applicant Parker Hannifin

K-Number K202480

View Details →

NKB 2021-04-22

ARx Spinal System

Applicant Life Spine, Inc.

K-Number K210549

View Details →

FXX 2021-04-22

Disposable Medical Face Mask

Applicant Guangzhou Mei YI Kang Medical Technology Co., Ltd.

K-Number K203646

View Details →

JDR 2021-04-22

Medline UNITE REFLEX Nitinol Staple System

Applicant Medline Industries, Inc.

K-Number K210482

View Details →

LPH 2021-04-22

Restoration Anatomic Shell

Applicant Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

K-Number K210893

View Details →

Page 1356 of 2685

↑