13 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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MODIFICATION TO PROFILE -II
FDA 510(k)
FDA Unclassified
·Unknown
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 3, 2025
Metal Custom Rx
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746104220·BRACKET INTER TWIN MAND LEFT BICUSPID 018 TQ=-2...
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026
MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
FDA 510(k)
FDA Class 2
·Cardiovascular
KYPHON XPANDER II EU
FDA Adverse Event
Malfunction
·KYPHON NEUCHATEL·Product code HRX·March 13, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·February 8, 2011
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code LDD·February 26, 2008
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 3, 2025
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013