8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
DORROS-SPRING PRESSURIZER
FDA 510(k)
FDA Class 2
·Cardiovascular
UniTip Catheter
FDA UDI
Unisensor AG·07640172973547·
Hyper GP (tisilfocon A) Daily Wear Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
ADC 656 ELECTRONIC STETHOSCOPE
FDA 510(k)
FDA Class 2
·Cardiovascular
INFUSOMAT SPACE PUMP IV SETS
FDA Adverse Event
BBRAUN OF CANADA (SUBSIDIARY OF BBRAUN MEDICAL)·Product code FPA·May 7, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·October 31, 2012
PUMP MMT-722NAH PRDGM INS PK
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 20, 2010
30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red Cap, Item No. CL 3011 Clerestories devices intended for the infusion and withdrawal of fluids.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·April 6, 2016