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 2023-07-25

Sonio Detect

Applicant Sonio

K-Number K230365

View Details →

PBQ 2023-07-25

Apyx

Applicant Escala Medical

K-Number K230730

View Details →

JGS 2023-07-25

A-LYTE® Integrated Multisensor (IMT Na K Cl)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K222438

View Details →

LBH 2023-07-24

Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)

Applicant Kettenbach GmbH & Co. KG

K-Number K230333

View Details →

LZA 2023-07-24

Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl

Applicant Central Medicare Sdn Bhd

K-Number K223752

View Details →

EBF 2023-07-24

EsCom250

Applicant Spident Co., Ltd.

K-Number K231523

View Details →

QJU 2023-07-24

UltraSight AI Guidance

Applicant Ultrasight, Inc.

K-Number K223347

View Details →

LLZ 2023-07-24

Argus Cognitive ReVISION Software

Applicant Argus Cognitive, Inc.

K-Number K223322

View Details →

BSZ 2023-07-23

Atlan

Applicant Drägerwerk AG Co. Kgaa

K-Number K230931

View Details →

OLI 2023-07-21

Erchonia Violet ZERONA® Z6 OTC

Applicant Erchonia Corporation

K-Number K231474

View Details →

LZA 2023-07-21

KIMTECH Polaris Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid

Applicant Kimberly-Clark Corporation

K-Number K231021

View Details →

MBH 2023-07-21

Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System

Applicant Conformis, Inc.

K-Number K223316

View Details →

Page 763 of 2685

↑