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

KTT 2022-04-08

Drive Rail System

Applicant OrthoPediatrics Corp.

K-Number K220809

View Details →

QDB 2022-04-08

Fitbit Irregular Rhythm Notifications

Applicant Fitbit, Inc.

K-Number K212372

View Details →

MUJ 2022-04-08

INT Contour

Applicant Carina Medical, LLC

K-Number K212274

View Details →

GAG 2022-04-08

ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler

Applicant Ethicon Endo-Surgery, LLC

K-Number K213633

View Details →

MOS 2022-04-08

Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T

Applicant Noras Mri Products GmbH

K-Number K220144

View Details →

NKB 2022-04-08

CD Horizon Spinal System and PASS LP Spinal System

Applicant Medicrea International

K-Number K220724

View Details →

IYN 2022-04-08

ImaCor Zura Handheld ZHH-010

Applicant Imacor, Inc.

K-Number K220490

View Details →

HAW 2022-04-08

visor2 system

Applicant Eemagine Medical Imaging Solutions GmbH

K-Number K210109

View Details →

LYY 2022-04-08

Latex Examination Gloves, Powder Free

Applicant Shandong Intco Medical Products Co, Ltd.

K-Number K213509

View Details →

FIE 2022-04-08

DORA Disposable A.V. Fistula Needle Sets

Applicant Bain Medical Equipment (Guangzhou) Co., Ltd.

K-Number K213015

View Details →

CAW 2022-04-08

Oxygen Concentrator

Applicant Foshan Mic Medical Technology Co., Ltd.

K-Number K202389

View Details →

LYY 2022-04-08

Non-sterile, Powder-Free Latex Examination Glove

Applicant Sri Trang Gloves (Thailand) Public Company Limited

K-Number K212309

View Details →

Page 1111 of 2685

↑