N/A

FDA UDI

PENTAX OF AMERICA, INC.·04961333242498·CBL, DVI MALE TO MALE 10

NA

FDA UDI

NIHON KOHDEN AMERICA, INC.·00841983102011·Cable (DVI, Serial, Sound, Alarm),G9

Nexxis

FDA UDI

Barco NV·05415334000940·MNA-120 ENC DVI AUDIO TMS

ACIST CVi® Cart

FDA UDI

ACIST MEDICAL SYSTEMS, INC.·10841716100076·CVi Cart, p/n 701351-001

ZEROWIRE

FDA UDI

Nds Surgical Imaging LLC·00851455007669·ZEROWIRE DUO, DVI, SDI, SINGLE CHANNEL

ZEROWIRE

FDA UDI

Nds Surgical Imaging LLC·00851455007287·UPGRADE KIT, ZEROWIRE ULTRA DUO, DVI

ACIST CVi® Angiographic Injection System Injector Head

FDA UDI

ACIST MEDICAL SYSTEMS, INC.·10841716101233·CVi Injector, p/n 700706-009

CVi® Cable

FDA UDI

ACIST MEDICAL SYSTEMS, INC.·30841716101091·CVi cable, p/n 700658-002

Messer France

Manufacturer

🇫🇷 France·11 Basic UDI-DIs·16 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·EUFLEXXA (1% SODIUM HYALURONATE)

FST COUNCIL TIP FOLEY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FST CATH-UD CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FST CATH UD-DUAL DUAL PRESSURE CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URO-PRO 2000

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FST CATH-UD, CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FST CATH-UD CATHETER, MODIFICATION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology