12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II
FDA 510(k)
FDA Class 2
·Orthopedic
MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
VAMP Venous/Arterial Blood Management Protection System
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPIOX HEMOCONCENTRATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code KDI·March 3, 2016
TRUWAVE, VAMP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025
DAVINCI
FDA Adverse Event
INTUITIVE SURGICAL, INC.·Product code NAY·February 15, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 19, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 1, 2014
TRUWAVE, VAMP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code KRA·April 18, 2025
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
FDA Recall
Terminated
·Cardio Medical Products·Product code LDD·April 26, 2013
TRUWAVE, VAMP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
FDA Enforcement
Class II
·Terminated·Cardio Medical Products·July 17, 2013