Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

MCW 2021-06-14

2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System

Applicant Volcano Atheromed, Inc.

K-Number K211518

View Details →

CAF 2021-06-14

Corrugated tube with mouthpiece accessory

Applicant Trudell Medical International

K-Number K203400

View Details →

FXX 2021-06-14

Surgical Face Mask

Applicant Shandong Haidike Medical Products Co., Ltd.

K-Number K210518

View Details →

EBG 2021-06-14

E-Temp

Applicant Envisiontec GmbH

K-Number K211101

View Details →

IOR 2021-06-14

Manual Wheelchair (Model W28)

Applicant Jiangsu Jumao X-Care Medical Equipment Co., Ltd.

K-Number K200466

View Details →

LON 2021-06-14

VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)

Applicant bioMerieux, Inc.

K-Number K211136

View Details →

CAF 2021-06-14

Ultrasonic Mesh Nebulizer

Applicant Shenzhen Ivankaca Technology Co., Ltd.

K-Number K201397

View Details →

LZA 2021-06-13

Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Ansell Healthcare Products, LLC

K-Number K210401

View Details →

FLL 2021-06-11

Radius T wearable thermometer

Applicant Masimo Corporation

K-Number K203215

View Details →

FRA 2021-06-11

EOS Air Cleaner

Applicant Guangzhou Ajax Medical Equipment Co., Ltd.

K-Number K202766

View Details →

EMA 2021-06-11

PANAVIA Veneer LC

Applicant Kuraray Noritake Dental, Inc.

K-Number K210504

View Details →

KGO 2021-06-11

POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS

Applicant Wrp Asia Pacific Sdn. Bhd.

K-Number K203030

View Details →

Page 1398 of 2744

↑