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 2024-09-10

8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads

Applicant Intuitive Surgical, Inc.

K-Number K241638

View Details →

DTK 2024-09-10

Option ELITE Vena Cava Filter System (352506070E 352506100E)

Applicant Argon Medical Devices, Inc.

K-Number K242612

View Details →

KWS 2024-09-10

Tornier Humeral Reconstruction System (Tornier HRS)

Applicant Stryker Corporation (Tornier, Inc.)

K-Number K241609

View Details →

INI 2024-09-10

Mobility Scooter

Applicant Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

K-Number K240990

View Details →

QIH 2024-09-10

LumiNE US; Lumi

Applicant Augmedit B.V.

K-Number K240094

View Details →

FYA 2024-09-10

ProPel SG3™ Surgical Gown

Applicant Standard Textile Co., Inc.

K-Number K241214

View Details →

GEX 2024-09-09

FoLix

Applicant Lumenis Be, Ltd.

K-Number K242349

View Details →

QIH 2024-09-09

ADAS 3D

Applicant Adas3D Medical S.L.

K-Number K240791

View Details →

OHT 2024-09-09

Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K241205

View Details →

NKB 2024-09-09

Pitkar Spinal Pedicle Screw System

Applicant S.H.Pitkar Orthotools Pvt. , Ltd.

K-Number K240233

View Details →

QIH 2024-09-09

Overjet Image Enhancement Assist

Applicant Overjet, Inc.

K-Number K241681

View Details →

MQB 2024-09-09

Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)

Applicant Rayence Co., Ltd.

K-Number K242394

View Details →

Page 533 of 2738

↑