11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EL CAPITAN Anterior Lumbar Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Avex CX
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205108074·Avex CX .018 LL5 D/HK (-17°T 2°A)
HAWKEYE™ Vertebral Body Replacement (VBR)
FDA UDI
Choice Spine, LP·00840996101066·VBR,SPACER,12X14X47,0 DEG
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551113911·HALO, CTLSO VEST SMALL, COOLMAX LINER, 1211-1 L...
Stiletto Extended Dwell Catheter
FDA 510(k)
FDA Class 2
·General Hospital
APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LZG·October 23, 2008
IMPELLA
FDA Adverse Event
Malfunction
·ABIOMED·Product code KFM·August 9, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 9, 2013
UROSKOP Omnia Max. Model Number: 10762473
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·June 25, 2025
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019