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

DTR 2023-04-13

Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)

Applicant Quara S.R.L.

K-Number K223879

View Details →

DZE 2023-04-13

Point implant system

Applicant Pointnix Co., Ltd.

K-Number K222738

View Details →

NXO 2023-04-13

ALPCO Calprotectin Immunoturbidimetric Assay

Applicant ALPCO

K-Number K220763

View Details →

EBI 2023-04-13

Trusana

Applicant Myerson, LLC

K-Number K230098

View Details →

KGO 2023-04-13

Sterile Nitrile Surgical Gloves Powder Free

Applicant Jr Engineering & Medical Technologies (M) Sdn. Bhd.

K-Number K222350

View Details →

KWQ 2023-04-12

Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral Lumbar Plate System

Applicant Omnia Medical, LLC

K-Number K230424

View Details →

DXN 2023-04-12

Task Force CORE

Applicant Cnsystems Medizintechnik GmbH

K-Number K223332

View Details →

FPA 2023-04-12

Polyfusion IV Administration Sets

Applicant Poly Medicure Limited

K-Number K220312

View Details →

OOE 2023-04-12

Catalys Precision Laser System

Applicant Amo Manufacturing USA, LLC

K-Number K223838

View Details →

NRY 2023-04-11

Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set

Applicant Route 92 Medical, Inc.

K-Number K223530

View Details →

PUL 2023-04-11

ZeptoLink IOL Positioning System

Applicant Centricity Vision, Inc.

K-Number K223763

View Details →

EOQ 2023-04-11

Bronchoscope System

Applicant Shenzhen HugeMed Medical Technical Development Co., Ltd.

K-Number K222910

View Details →

Page 839 of 2685

↑