9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACTIVAPATCH ET IONTOPHORESIS PATCH
FDA 510(k)
FDA Class 2
·Physical Medicine
IRRIGATION SETS
FDA 510(k)
FDA Class 2
·Orthopedic
EYE CARE CURE CONTACT LENS CASE
FDA 510(k)
FDA Class 2
·Ophthalmic
GMK CEMENTED STD FEMUR SIZE 4 LEFT - NARROW
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·January 8, 2015
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 29, 2013
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·September 29, 2014
HI-TORQUE PILOT GUIDE WIRE
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code DQX·June 17, 2011
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
FDA Enforcement
Class I
·Ongoing·Edwards Lifesciences, LLC·July 16, 2025
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023