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

FDT 2024-08-01

PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )

Applicant Pentax of America, Inc.

K-Number K233942

View Details →

HRS 2024-08-01

Freefix Forearm Plating System

Applicant Skeletal Dynamics, Inc.

K-Number K242055

View Details →

EBZ 2024-08-01

LOOP LED Curing Light System (CLK01)

Applicant Garrison Dental Solutions, LLC

K-Number K241238

View Details →

DYB 2024-08-01

TLAB® Transvenous Liver Biopsy System (TF-18C)

Applicant Argon Medical Devices, Inc.

K-Number K241145

View Details →

NXC 2024-08-01

Clear Moves Aligner

Applicant Clear Moves Aligners

K-Number K241137

View Details →

QDQ 2024-08-01

MammoScreen® (3)

Applicant Therapixel

K-Number K240301

View Details →

KCT 2024-07-31

SteriTite rigid reusable sterilization container with MediTray Products

Applicant Case Medical

K-Number K240898

View Details →

DZE 2024-07-31

LW Narrow Implant System

Applicant Ossvis Co., Ltd.

K-Number K233808

View Details →

CDD 2024-07-31

ARCHITECT Active-B12 (Holotranscobalamin)

Applicant Axis-Shield Diagnostics, Ltd.

K-Number K233541

View Details →

ETN 2024-07-31

EARP Nerve Cuff Electrode

Applicant Retropsoas Technologies, LLC

K-Number K241917

View Details →

BZD 2024-07-31

AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask

Applicant Philips Respironics

K-Number K233555

View Details →

FRO 2024-07-31

Silverlon® Wound Contact, Burn Contact Dressing

Applicant Argentum Medical, LLC

K-Number K241225

View Details →

Page 485 of 2685

↑