10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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APTUS® Foot 2.8-3.5 System
FDA 510(k)
FDA Class 2
·Orthopedic
LUMINOS LOTUS MAX
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code OWB·March 5, 2025
VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC
FDA 510(k)
FDA Class 2
·Anesthesiology
SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500
FDA 510(k)
FDA Class 2
·Ophthalmic
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2014
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·July 14, 2011
PELVREDUCFORCEPS SM F/SCR Ø3.5 L250
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTD·June 27, 2013
LASSOSTARNAV,10P,15MM DIA LOOP
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code DRF·February 22, 2023
LASSOSTAR CATHETER
FDA Adverse Event
Death
·BIOSENSE WEBSTER INC.·Product code DRF·December 30, 2020
LASSOSTAR NAV CIRCULAR MAPPING CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DRF·November 23, 2022