11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)
FDA 510(k)
FDA Class 2
·Cardiovascular
BELMONT BUDDY PLUS FLUID WARMER
FDA 510(k)
FDA Class 2
·Hematology
VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER
FDA 510(k)
FDA Class 2
·General Hospital
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
WEREWOLF RF 20000 CONTROLLER
FDA Adverse Event
Malfunction
·ARTHROCARE CORP.·Product code GEI·June 29, 2020
ECHELON*FLEX45
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 11, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·September 8, 2008
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026