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 2021-03-26

i-ED COIL System

Applicant Kaneka Medical America, LLC

K-Number K210638

View Details →

NUP 2021-03-26

AllerBlock Junior

Applicant Nasaleze International, Ltd.

K-Number K201734

View Details →

MAX 2021-03-26

Lucent 3D Spinal System

Applicant Spinal Elements, Inc.

K-Number K203254

View Details →

NUH 2021-03-25

Low-frequency Multi-function physiotherapy instrument

Applicant Shenzhen Kentro Medical Electronics Co., Ltd.

K-Number K200177

View Details →

LZA 2021-03-25

Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs

Applicant Shen Wei USA, Inc.

K-Number K202083

View Details →

OUR 2021-03-25

FIREBIRD SI Fusion System

Applicant Orthofix, Inc.

K-Number K210667

View Details →

FXX 2021-03-25

Surgical Masks, Model SNN200640 & MN112

Applicant Sq Medical Supplies, Inc.

K-Number K203776

View Details →

MTV 2021-03-25

NeedleSmart Professional (NS Pro)

Applicant Needlesmart Limited

K-Number K202073

View Details →

MBH 2021-03-25

LEGION Porous CR Narrow Femoral Components

Applicant Smith & Nephew, Inc.

K-Number K210566

View Details →

KIF 2021-03-25

DiaPaste

Applicant DiaDent Group International

K-Number K210333

View Details →

FYD 2021-03-25

NEBULAE SRS Laparoscopic Surgical Smoke Removal System

Applicant Northgate Technologies, Inc.

K-Number K202944

View Details →

KCT 2021-03-25

ST-Z5

Applicant Z-Systems AG

K-Number K201878

View Details →

Page 1375 of 2685

↑