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

IYN 2021-09-08

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

Applicant Philips Medical Systems

K-Number K211597

View Details →

DXN 2021-09-08

Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM

Applicant Health & Life Co., Ltd.

K-Number K211127

View Details →

JOW 2021-09-08

CIRCUL8 Luxe DVT Prevention Device

Applicant Ortho8, Inc.

K-Number K211235

View Details →

HIR 2021-09-08

Leva Pelvic Health System

Applicant Renovia, Inc.

K-Number K212495

View Details →

NDC 2021-09-08

BlueStar Rx

Applicant Welldoc, Inc.

K-Number K203434

View Details →

QIH 2021-09-08

AmCAD-UT

Applicant Amcad Biomed Corporation

K-Number K203555

View Details →

QQI 2021-09-08

FEops HEARTguide

Applicant Feops NV

K-Number DEN200030

View Details →

FXX 2021-09-08

Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask

Applicant Zhejiang Lanhine Medical Products, Ltd.

K-Number K211832

View Details →

IYN 2021-09-08

V8 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K211945

View Details →

MUJ 2021-09-08

RayStation 11.0

Applicant RaySearch Laboratories AB (PUBL)

K-Number K211867

View Details →

FMF 2021-09-08

Verifine Mechanical Safety Insulin Syringe

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K210712

View Details →

MED 2021-09-07

SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate

Applicant STERIS Corporation

K-Number K211607

View Details →

Page 1262 of 2685

↑