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

EBF 2021-09-22

ACTIVA PRESTO PACK

Applicant Pulpdent Corporation

K-Number K210045

View Details →

EOQ 2021-09-22

Single Use Guide Sheath Kit-401, K-402

Applicant Olympus Medical Systems Corp.

K-Number K212667

View Details →

FXX 2021-09-22

3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)

Applicant Vr Vertical, LLC Dba Xrgo

K-Number K210772

View Details →

LZO 2021-09-22

Mpres Neck Preserving Stem

Applicant Medacta International S.A.

K-Number K210263

View Details →

MQV 2021-09-22

DB-EZ Bone Void Filler

Applicant Dimensional Bioceramics, LLC

K-Number K212353

View Details →

ITI 2021-09-22

Electric Wheelchair (XW-LY001)

Applicant Yongkang Dingchang Industry & Trade Co., Ltd.

K-Number K200423

View Details →

DXH 2021-09-22

SimpleSENSE Platform

Applicant Nanowear, Inc.

K-Number K212160

View Details →

QDP 2021-09-22

FilmArray Pneumonia Panel

Applicant Biofire Diagnostics, LLC

K-Number K212727

View Details →

NXC 2021-09-22

Smylio Invisible Clear Aligners

Applicant Smylio, Inc.

K-Number K212660

View Details →

FXX 2021-09-22

Banyan USA Surgical Mask Level 3

Applicant Banyan USA, LLC

K-Number K211097

View Details →

MAX 2021-09-22

IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System

Applicant Alphatec Spine, Inc.

K-Number K211805

View Details →

LZA 2021-09-21

Disposable Nitrile Examination Gloves

Applicant Foshan Kangkang Biotechnology Co., Ltd.

K-Number K211073

View Details →

Page 1252 of 2685

↑