8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
POSIVAC
FDA 510(k)
FDA Class 2
·Anesthesiology
Advanced Intermezzo Implant System
FDA 510(k)
FDA Class 2
·Dental
LONG HANDLED BATH BRUSH
FDA 510(k)
FDA Class 1
·Physical Medicine
UNIFY QUADRA CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·May 5, 2014
REVO MRI SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWP·October 15, 2012
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 30, 2010
ULTRACLEAN ELECTRODE 1"BLADE EXTENDED INSULATION
FDA Adverse Event
Malfunction
·CONSOLIDATED MEDICAL EQUIPMENT·Product code GEI·January 3, 2020
Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 100047194; CD3211-36Q/100004091, 100004093,100019784, 100035620, 100042486, 100047054; CD3215-36/100006995, 100010246, 100010247, 100010249, 100010250, 100012569, 100012570, 100034981, 100046577, 100046802, 60019065; CD3215-36Q/100004059, 100004060, 100004061, 100023304, 100030590, 100033678, 100042492, 100046803, 100046906
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018