21 results · 41ms · Sources: EU EUDAMED, US FDA

Shockwave M5 Intravascular Lithotripsy (IVL) Catheter

FDA registration
Nitinol Devices & Components Costa Rica, S. R. L.·1 product·🇨🇷 Costa Rica

Synergy Health AST, LLC

FDA registration
Synergy Health AST, LLC·1 product·🇺🇸 United States

Peripheral Intravascular Lithotripsy (IVL) System

FDA registration
SHOCKWAVE MEDICAL, INC.·1 product·🇺🇸 United States

Synergy Health AST, SRL

FDA registration
Synergy Health AST, SRL·1 product·🇨🇷 Costa Rica

Shockwave Medical Peripheral Intravascular Lithotripsy, Shockwave M5 IVL Catheter, IVL Generator and Connector Cable

FDA registration
VANGUARD-EMS·1 product·🇺🇸 United States

Synergy Health AST, LLC

FDA registration
Synergy Health AST, LLC·1 product·🇺🇸 United States

ONANON, INC

FDA registration
ONANON, INC·1 product·🇺🇸 United States

Synergy Health AST, SRL

FDA registration
Synergy Health AST, SRL·1 product·🇨🇷 Costa Rica

Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable

FDA 510(k)
FDA Class 2 ·Cardiovascular

Percutaneous Catheter, Ultrasound

FDA classification
FDA Class 2 ·Percutaneous Catheter, Ultrasound

iO-Flex

FDA registration
SPINAL ELEMENTS, INC.·1 product·🇺🇸 United States

Sterigenics US LLC

FDA registration
Sterigenics US LLC·1 product·🇺🇸 United States

Sterigenics U.S., LLC

FDA registration
Sterigenics U.S., LLC·1 product·🇺🇸 United States

Sterigenics US LLC

FDA registration
Sterigenics US LLC·1 product·🇺🇸 United States

VersaJet II Hydrosurgery System

FDA registration
Smith & Nephew, Inc.·1 product·🇺🇸 United States

Batallion

FDA registration
Sterigenics U.S., LLC·2 products·🇺🇸 United States

SpeediCath accessories

FDA registration
Sterigenics Belgium Petit Rechain S.A.·1 product·🇧🇪 Belgium

MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·Neurology

VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH

FDA 510(k)
FDA Class 2 ·General Hospital

Rongeur, Manual

FDA classification
FDA Class 2 ·Rongeur, Manual