FDA.reportPublic FDA data

STERIS SPA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30069484783006948478STERIS SPA1N2020-04-25via A. Piva Poggio Rusco Mantova IT 46025

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1766081286396917K994209STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIPDWF2000-06-14
1766081087982149K992599DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIRDTN1999-11-01
1766081670769833K984322DIDECO D920, LILLIPUT 1 TWIN RESERVOIRDTP1999-03-02
1766081331352249K980600D903 AVANT ADULT HOLLOW FIBER OXYGENATORJOW1998-08-12
1766081953779669K974897COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SETCAC1998-03-31
1766081451214154K963758CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINECAC1998-02-20
1766081577112264K952270DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREENDTM1995-08-21
1766081827444245K941215VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIRDTN1995-05-10
1766081486024043K934847NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMSDTN1994-04-15
1766081024112766K934779AGRAM SPYRAL ELECTRODEGXZ1995-03-14
1766081119745316K902671COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTERCAC1990-07-17
1766081993138302K902437COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTERDTP1990-12-17
1766081400819621K900339HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLESDTS1990-03-28
1766081799677671K890980MODIFIED STOCKERT-SHILEY VENOUS CATHETERDWF1989-05-01
1766081994644190K884872DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIRDTN1989-01-30
1766081508153881K872162DIDECO-SHILEY BLOOD REINFUSION BAGCAC1987-07-21
1766081220735580K872159DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIESDWF1987-08-12
1766082066104515K872158DIDECO-SHILEY WASTE COLLECTION BAGCAC1987-07-21
1766081901447410K870826ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN.DQR1987-03-23
1766081883145562K870825NEW MODEL STYLES FOR AORTIC ARCH CANNULADQR1987-03-23
1766081299953463K864937'EXMOOR' ZOELLNER SUCKER ENDSJOL1987-03-30
1766081574959070K861496STOCKERT-SHILEY VENOUS CATH & AORTIC ARCH CANNULADWF1986-05-27
1766081648635634K861310STOCKERT-SHILEY AORTIC ROOT CANNULAEDWF1986-05-30
1766081020723591K844803POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTEDTP1985-04-29
1766081338298551K844140STOCKERT-SHILEY ATRIAL LEFT VENTRICULAR VENT CATHDWF1984-12-27
1766081792170313K844139STOCKERT-SHILEY INTRACARDIAC SUCKERSDWF1984-12-27
1766081322846156K844137STOCKERT-SHILEY VENOUS CATHETER & AORTIC ARCH CANNDWF1984-12-27
1766081035458980K191963SMR Finned Short StemsMBF2019-10-10
1766082043721976K191746SMR TT Augmented Glenoid SystemPHX2019-11-22
1766081054867233K191622Delta Multihole TT Pro Acetabular SystemLPH2019-11-01
1766081018662418K183042SMR Lateralized Connectors with screwsKWS2019-01-25
1766081334271429K182099Delta TT ProLPH2018-12-26
1766081004793282K181491Delta Dual Mobility SystemLZO2019-05-09
1766081133529987K181362TEMA Elbow SystemJDC2019-02-16
1766081457734331K172456Bone Screws 6.5mmLPH2018-01-04
1766081515986181K170473C2 femoral stemLZO2017-11-08
1766081611871257K163397SMR Hybrid Glenoid SystemMBF2017-06-29
1766081781639827K161476SMR Shoulder SystemKWT2016-06-24
1766081111030795K161226Revision Femoral StemLZO2017-02-10
1766081079376140K160011H-Max S stemMEH2016-08-22
1766081640434363K152008Physica PS Knee SystemJWH2015-10-29
1766081013422001K151739Revision Femoral StemLZO2015-11-23
1766081027466156K150489EOS PMP, EOS PMP IntegratedDTZ2015-06-11
1766081846029188K142139SMR 40MM GLENOSPHEREPHX2014-11-07
1766081755803947K141934PHYSICA KR KNEE SYSTEMJWH2015-04-02
1766081076752154K141395DELTA TT ACETABULAR SYSTEMLPH2014-06-30
1766081919271652K141327MINIMA S SYSTEMLZO2014-08-06
1766081313044631K140975MASTERSL FEMORAL STEMLZO2014-06-10
1766081811765849K133349SMR TT METAL BACK GLENOIDKWS2014-06-03
1766081220365410K131112LIMACORPORATE SMR CTA HUMERAL HEADSKWS2013-06-07
1766081433168449K131103XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIRDTN2013-06-06
1766081037640379K130433INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATEDTZ2013-03-20
1766081271058666K130209INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATEDDTZ2013-02-12
1766081760300094K122844INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIRDTZ2012-10-17
1766081803848383K122254INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIRDTZ2012-08-24
1766081117709850K121909INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIORDTZ2012-07-26
1766081608042298K121536INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIRDTZ2012-08-22
1766081698566775K121229INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMYDTZ2012-07-23
1766081948181813K120185INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIORDTZ2012-05-11
1766081841360544K120026PERFORMER HT/ HANG&GO HT BASICLGZ2012-05-08
1766081987357514K113626INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIRDTZ2012-04-05
1766081176149770K113523LIMACORPORATE SMR REVERSE SHOULDER SYSTEMPHX2011-12-20
1766081132775942K113254SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWSPHX2012-02-24
1766081449884842K112900SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADSHSD2012-06-01
1766081766542267K112898DELTA TT CUPS, DELTA TT LINERS, BONE SCREWSLPH2012-12-21
1766081123128724K112771BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAGDTN2011-10-14
1766081631718499K112525D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERSDTM2011-09-29
1766081480864499K112158MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADSLPH2012-05-10
1766081098928094K110847SMR SHOULDER SYSTEM - CTA HUMERAL HEADSKWS2011-07-15
1766081254066533K110598SMR REVERSE SHOULDER SYSTEMPHX2011-08-18
1766081915750178K103202PREASSEMBLED SURGICAL WASH SETCAC2010-11-23
1766081896061062K101586XTRA AUTOTRANSFUSION SYSTEMCAC2010-10-05
1766081297458732K101263LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES,KWT2011-01-28
1766081107149603K100858LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,KWT2010-12-10
1766081364084926K100507XRES BLOOD COLLECTION RESERVOIRDTN2010-03-24
1766081983387109K093986AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERSDTM2010-01-22
1766081107567516K093601AF 840 PH.I.S.I.O. ARTERIAL FILTERDTM2009-12-18
1766081565837534K092895APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATORDTZ2009-10-19
1766081674006236K092463SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEMDTQ2009-11-05
1766081436679599K092315SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIRDTN2009-08-12
1766081318590962K083021APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATORDTZ2008-10-29
1766081483829722K081313SH14 HEMOCONCENTRATORKDI2008-11-19
1766081504395875K073380SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOIDTZ2008-02-29
1766081519661797K072308D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATEDDTM2007-09-12
1766081639230892K072091D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIRDTZ2007-10-29
1766081100502292K063255D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATEDDTM2007-01-11
1766081284216700K061527CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATINGDTN2006-06-27
1766081129893170K061031D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR WDTZ2006-06-02
1766081353819611K052717D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTERDTM2005-10-20
1766081166065253K050890ECC.O SYSTEMKFM2005-05-05
1766081259300027K050447PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATORDTZ2005-03-08
1766081570578371K050111SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAGDTN2005-03-08
1766081634887236K043323D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIRDTZ2005-02-01
1766081195998679K041061D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERSDTM2004-05-06
1766081438223164K040184DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTERDTM2004-02-26
1766081284199280K033987D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERSDTM2004-01-08
1766081366522610K033323D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATINGDTZ2004-01-13
1766082031240858K032962AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACEFOZ2003-10-29
1766081305960864K032040IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATORKFM2003-07-09
1766081622455670K030462COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700KFM2003-03-06
1766081311434985K030154IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATORKFM2003-03-31
1766081385046332K023622STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35DWF2002-11-21
1766081103545622K022450INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMYDTZ2002-10-22
1766081620878301K022321STOCKERT V172-28 VENOUS FEMORAL CANNULADWF2002-10-09
1766081327953645K022280STOCKERT CORONARY PERFUSION CANNULAEDWF2002-10-11
1766081964498149K021830SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEMDTR2002-07-02
1766082071671225K021732DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULTKDI2002-11-04
1766081199115228K020997APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATORDTZ2002-04-04
1766081342551475K020647DIDECO ELECTACAC2002-09-05
1766081646811936K014080APEX ADULT HOLLOWE FIBER OXYGENATORDTZ2002-01-08
1766081421021104K012898MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEMDTR2001-09-17
1766081837294456K011835COBE REVOLUTIONKFM2002-02-12
1766081411968089K002273STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAEDWF2001-01-29
1766082048202584K001961STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAEDWF2001-01-25
1766081738286263K001509STOCKERT V172 SERIES VENOUS FEMORAL CANNULAEDWF2001-10-26
1766081338440689
1766081619187583
1766081626839272
1766081866654363
1766081878890894

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DTZ212015-06-11
DWF142002-11-21
DTN102013-06-06
DTM102011-09-29
CAC82010-11-23
LPH62019-11-01
LZO62019-05-09
PHX52019-11-22
KFM52005-05-05
KWS42019-01-25
KWT32016-06-24
DTP31999-03-02
MBF22019-10-10
JWH22015-10-29
KDI22008-11-19
DTR22002-07-02
DQR21987-03-23
JDC12019-02-16
MEH12016-08-22
HSD12012-06-01
LGZ12012-05-08
DTQ12009-11-05
FOZ12003-10-29
JOW11998-08-12
GXZ11995-03-14
DTS11990-03-28
JOL11987-03-30