12 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Fiber Laser Treatment Systems (HS-232,HS-233)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251031200·ceraMotion® Ti Base Dentin C2, 20 g / dental ce...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251031400·ceraMotion® Ti Base Dentin C2, 40 g / dental ce...
Virage OCT Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·June 12, 2024
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 14, 2014
SKIN PREP WIPES
FDA Adverse Event
Injury
·SMITH & NEPHEW WOUND MANAGEMENT·Product code NEC·September 16, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·July 29, 2013
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·June 12, 2024
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic graft, and cardioroot configurations designed for use on the thoracic aorta
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 29, 2022
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·June 12, 2024