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

NAY 2022-01-31

8mm Monopolar Curved Scissors

Applicant Intuitive Surgical, Inc.

K-Number K220023

View Details →

JHI 2022-01-31

Alltest Pregnancy Rapid Combo Test Cassette

Applicant Hangzhou AllTest Biotech Co., Ltd.

K-Number K203272

View Details →

KLE 2022-01-31

DIAPLUS Universal

Applicant DiaDent Group International

K-Number K213401

View Details →

MQB 2022-01-31

SKR 3000

Applicant Konica Minolta, Inc.

K-Number K213908

View Details →

FXX 2022-01-28

Surgical Masks

Applicant Hubei Xinxin Non-Woven Co., Ltd.

K-Number K212120

View Details →

GEI 2022-01-28

ShinEvac Smoke Evacuation Pencil

Applicant Shining World Health Care Co., Ltd.

K-Number K213317

View Details →

IYN 2022-01-28

X-CUBE i8, X-CUBE i9

Applicant Alpinion Medical Systems Co., Ltd.

K-Number K213523

View Details →

BTT 2022-01-28

Optiflow Oxygen Kit

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K211096

View Details →

GXQ 2022-01-28

SyntheCel Dura Repair

Applicant Synthes (USA) Products, LLC

K-Number K212943

View Details →

FLL 2022-01-28

Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311

Applicant Guangzhou Berrcom Medical Device Co., Ltd.

K-Number K213082

View Details →

QAS 2022-01-28

syngo.CT Brain Hemorrhage

Applicant Siemens Medical Solutions USA, Inc.

K-Number K203260

View Details →

KLE 2022-01-28

STEP-1 PumEtch

Applicant Rounding Third, LLC

K-Number K213093

View Details →

Page 1227 of 2738

↑