8 results
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25ms
·
Sources: EU EUDAMED, US FDA
SUCTION-HEMORRHOID-LIGATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V
FDA 510(k)
FDA Class 2
·General Hospital
BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 14, 2012
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·May 27, 2014
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 13, 2010
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601617931, REF/Catalog No. 60161793, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc·March 4, 2015
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