FDA.reportPublic FDA data

STERIS CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10435721043572STERIS CORPORATION1N2026-01-012720 GUNTER PARK DRIVE EAST MONTGOMERY AL US 36109
15265311526531STERIS Corporation1N2026-01-0117820 ENGLEWOOD DR. CLEVELAND OH US 44130
15278211527821STERIS CORPORATION1Y2026-01-015960 Heisley Road Mentor OH US 44060
19235691923569STERIS Corporation1N2026-01-015 SUNNEN DR. Saint Louis MO US 63143
19334431000510740STERIS CORPORATION1N2026-01-018525 Page Ave Breckenridge Hills MO US 63114
19375311937531STERIS CORPORATION1N2026-01-017501 Page Ave Saint Louis MO US 63133
21838282183828STERIS Laboratories1N2026-01-019303 West Broadway Ave. Brooklyn Park MN US 55445
26486232648623STERIS ISOMEDIX PUERTO RICO, INC.1N2026-01-01KM 1 7, STATE Road, 690 BARRIO SABANA HOYOS Alts De Cerro Gordo 3&4 PR US 00692
96803533004097451STERIS Canada ULC1N2026-01-01490 Boulevard Armand-Paris QUEBEC CA G1C 8A3
30002512743000251274STERIS Corporation1N2026-01-016515 HOPKINS RD. Mentor OH US 44060
30028066033002806603STERIS SPA1N2026-01-013, 5, 7, 9, VIA EINAUDI CALCINATE Bergamo IT 24050
30039502073003950207STERIS Corporation1Y2026-01-016100 Heisley Rd Mentor OH US 44060
30040809203004080920STERIS CORPORATION1N2026-01-019325 Pinecone Drive Mentor OH US 44060
30047845373004784537STERIS AST CZ s.r.o.1N2026-01-01PRUMYSLOVA ZONA KOSIKOV VELKA BITES Vyso?ina CZ 595 01
30058444693005844469Sterisil1N2026-01-014220 Mark Dabling Blvd Colorado Spgs CO US 80907
30065549123006554912STERIS Deutschland GmBh1N2026-01-01KANTSTRASSE 33/1 Wurmlingen Baden-Wurttemberg DE D-78573
30074128093007412809STERIS Corporation1N2026-01-0111457 MELROSE AVE FRANKLIN PARK IL US 60131
30088240973008824097STERIS Sterilization Technologies (Suzhou) Ltd1N2026-01-01No26 Xinchang Road Suzhou Industrial Park Suzhou Jiangsu CN CP215125
30103838473010383847STERISERVICES1N2026-01-0120 rue des Canadiens Bernay Eure FR 27300
30104211043010421104STERIS TOMOE SINGAPORE PTE LTD1N2026-01-01No. 47 Jalan Buroh Unit # 01-01 Singapore South West SG 619491
30127088603012708860STERIS Italy S.r.l.1N2026-01-01Via Laurentina, 169 Pomezia Roma IT 00071
30146808343014680834STERIS1N2026-01-01701 Cornell Dr Bldg F Unit 1 2 & 3 Wilmington DE US 19801
30162715783016271578STERIS IPS1N2026-01-011000 Parliament Ct. Durham NC US 27703
30176367373017636737STERIS Corporation de Republica Dominicana, S.R.L.1N2026-01-01Zona Franca Las Americas KM. 22 Autopista las Americas Santo Dom Calle 15 esq. Calle 10 Santo Domingo Santo Domingo DO 00000
30301250443030125044STERIS S.p.A.1N2026-01-01Monza Via Parco, 47 Biassono Monza e Brianza IT 20853

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10885403018947V. Mueller - GENESIS HALF-LENGTH CONTAINER 11 X 12 inches27.9 X 30.5CM 4 inches10CM DEEP PERFORATED BOTTOM+1(800)548-4873xx@xx.xx
10885403018954V. Mueller - GENESIS HALF-LENGTH CONTAINER 11 X 12 inches27.9 X 30.5CM 4 inches10CM DEEP SOLID BOTTOM+1(800)548-4873xx@xx.xx
10885403018985V. Mueller - GENESIS HALF-LENGTH CONTAINER 11 X 12 inches27.9 X 30.5CM 5 inches12.7CM DEEP PERFORATED BOTTOM+1(800)548-4873xx@xx.xx
10885403018992V. Mueller - GENESIS HALF-LENGTH CONTAINER 11 X 12 inches27.9 X 30.5CM 5 inches12.7CM DEEP SOLID BOTTOM+1(800)548-4873xx@xx.xx
10885403019029V. Mueller - GENESIS HALF-LENGTH CONTAINER 11 X 12 inches27.9 X 30.5CM 6 inches15.2CM DEEP PERFORATED BOTTOM+1(800)548-4873xx@xx.xx
10885403019036V. Mueller - GENESIS HALF-LENGTH CONTAINER 11 X 12 inches27.9 X 30.5CM 6 inches15.2CM DEEP SOLID BOTTOM+1(800)548-4873xx@xx.xx
10885403019074V. Mueller - CONTAINER HALF-LENGTH 7 inches 17.8 CM DEEP LID SOLID+1(800)548-4873xx@xx.xx
10885403125676V. Mueller - CONTAINER HALF-LENGTH 8 inches 20.3 CM DEEP LID PERFORATED+1(800)548-4873xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1518981167593421P990034MEDTRONIC ISOMED INFUSION SYSTEMLKK2000-07-21
2014231102041546P980031INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTSLQE1999-04-09
2014231090575799P950002BAK INTERBODY FUSION SYSTEMMAX1996-09-20
1518981828611540P860004MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEMLKK1988-03-14
30041955623856P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
3299531420877555K992983BAHO AUTOCLAVABLE CYSTOSCOPEFAJ1999-10-07
3298981455740309K991928MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORSGCJ1999-06-25
3299531455740309K991928MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORSGCJ1999-06-25
3298981541781291K991589FLEXIBLE VASCULAR CLAMP, VERSION 2DXC1999-05-18
3299531541781291K991589FLEXIBLE VASCULAR CLAMP, VERSION 2DXC1999-05-18
3298931816585772K983299ALLEGIANCE GENESIS CONTAINER SYSTEMFRG2000-08-04
3298981816585772K983299ALLEGIANCE GENESIS CONTAINER SYSTEMFRG2000-08-04
3298981911533300K982465DEROYAL INDUSTRIES, INC. DEFOGGEROCT1998-08-11
3299531939484564K982365ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMATDXC1999-04-08
3299531726288020K982276BAHO AUTOCLAVABLE LAPAROSCOPEHET1999-02-18
30041403326825K982159ABBOTT PLUM A+ INFUSION PUMPFRN1999-01-12
3298981180304966K981956DEGANIA SILICONE IDENTI LOOPSDXC1998-07-09
3299531016881178K981919BISSINGER CABLES, CAT. NO. 801000XXGEI1998-08-06
30041351958061K980503TEMPORARY CARDIAC PACING WIRELDF1998-04-10
3298981265780500K974769COSGROVE CLAMPDXC1998-06-12
3298981266040206K974595CUSHING BAYONET, INSULATED BIPOLAR FORCEPHTD1998-06-24
3298981176002914K974594SEMKIN BIPOLAR FORCEPHTD1998-06-24
3298981380044464K974593SEMKIN INSULATED BIPOLAR FORCEPHTD1998-06-24
3299531454194321K974382ACKERMANN SURGICAL INSTRUMENTSGCJ1998-04-21
30041734237927K973195TOTAL PERFORMANCE SYSTEM SHAVERHRX1997-10-24
30041565761783K972584STRYKER HUMMER II MICRODEBRIDER SYSTEMERL1997-10-01
30041395263239K972069STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACKFQH1997-07-29
3298981686607091K971540AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORDGEI1997-08-14
2831621880384164K971307AMSCO SURGICAL TABLEFQO1997-06-27
3298931282494310K964402VERSATRAC (TM) LUMBAR RETRACTOR SYSTEMGZT1997-01-23
3298981282494310K964402VERSATRAC (TM) LUMBAR RETRACTOR SYSTEMGZT1997-01-23
30041686021109K963332THERMO-PLASTIC SHAVER BLADESHRX1996-10-11
3298931801508644K962545DENTAL, MEDICAL INSTRUMENT CASES & CASSETTEKCT1997-03-07
30041484803172K961122STRYKER KNIFELIGHTFTD1996-08-22
3298981713648361K951413FOGARTY-HYDRAGRIP SURGICAL CLAMPSDXC1995-08-18
3298981074094976K944025SURGICAL INSTRUMENT TRAYFSM1994-11-22
30041416861196K941605STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSHLXH1994-08-05
30041916187970K941333SE5 ARTHROSCOPY SYTEMHRX1994-11-10
30041157555105K941214LIFESHIELD EXTENSION SETFPK1994-10-03
30041688909730K940697BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCKFPA1994-08-30
1764551024112766K934779AGRAM SPYRAL ELECTRODEGXZ1995-03-14
30041429107814K934094STRYKER LAPAROSCOPIC SUCTION IRRIGATORGCJ1994-02-18
3298981862443917K931340GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTORGCS1993-07-01
3298981908634724K930667REUSABLE LAPAROSCOPIC INSTRUMENTSGCJ1994-05-16
3299531908634724K930667REUSABLE LAPAROSCOPIC INSTRUMENTSGCJ1994-05-16
3298982023137704K930666REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERYGEI1994-05-19
3299532023137704K930666REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERYGEI1994-05-19
2831621359285171K930493QUANTUM 3080 SURGICAL TABLEFQO1993-06-22
2831621014558824K930041VICROSAFE 6 AND VICROSAFE 12FYD1993-11-03
3298981743923421K925114LAPAROSCOPIC INSTRUMENTSHFI1994-02-28
3298982051561078K925079LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER)HET1994-08-24
2831621364690449K924732PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEMFYD1993-09-13
30041475675381K923915TORQR SERIES DIAGNOSTIC EP CATHETERSDRF1993-02-10
3298981118397587K914426ENTREE NEEDLEFHO1991-11-27
3298981257081863K913500CHERRY SPONGEGCJ1991-09-25
30041902406180K911401ABBOTT LIFECARE 5000 PUMPFRN1991-05-28
2831621040354760K905816ORTHOVISION TABLEJEB1991-03-06
30041717142635K904233CONVATEC ABSORBENT BANDAGEEXE1991-03-06
30041288914279K904223SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETSCAK1990-10-26
3298981013915138K904173INSULATED ELECTRODES AND LAPAROSCOPIC PROBICSHET1990-12-10
3298981469837627K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFST1990-04-23
1518981468007605K900590BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDINGKNT1990-08-02
2800271024116940K897045BOWIE-DICK TEST CARD CATALOG NUMBER 008018JOJ1990-02-15
3298981352298803K895395V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTORGZT1989-10-19
2014231718861183K894038PLUME-AWAY SMOKE EVACUATION SYSTEMFYD1989-09-28
2831621516366938K882660GENERAL SURGICAL TABLE AND ACCESSORIESFQO1988-07-25
1518982011390473K864938'EXMOOR' MOFFAT-ROBINSON BONE PATE COLLECTORLRC1987-03-23
2810371342172797K863122ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.FRC1986-12-17
2810372017740895K855101ASSERT TM BIOLOGICAL/CHEMICAL INDICATORFRC1986-07-17
2810371352582688K854902SURGICOT STEAM TEST PACKFRC1986-05-20
30041059798327K854077MIX EVAC IIJDZ1986-01-31
3298932033528204K844652C.A.S.E. CONTAINERFSM1984-12-12
3298982033528204K844652C.A.S.E. CONTAINERFSM1984-12-12
2800271615941978K844512DART DAILY AIR REMOVAL TESTJOJ1985-03-21
30041865018842K841362TIDAL DISTENSION IRRIGATION SETGBX1984-08-02
3298981494215198K811820BIPOLAR COAGULATING FORCEPSGEI1981-07-28
3299531494215198K811820BIPOLAR COAGULATING FORCEPSGEI1981-07-28
2810371610914726K800029SURGICOT 2 INDICATOR SYSTEMFRC1980-03-12
30042041325262K791774LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRANKPE1979-10-26
2810371385890581K260766Celerity 5 HP Biological Indicator (LCB052)FRC2026-04-08
2800271912387486K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED2026-04-08
2801111912387486K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED2026-04-08
2801311912387486K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED2026-04-08
2809141912387486K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED2026-04-08
2810371053960754K251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)FRC2025-06-06
2800271449200962K250061Celerity IncubatorFRC2025-02-06
2810371934561610K250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)FRC2025-02-06
2800091048865730K243876VERIFY STEAM Integrating IndicatorJOJ2025-04-25
2800271048865730K243876VERIFY STEAM Integrating IndicatorJOJ2025-04-25
2800271615144654K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemFEB2024-12-02
2801111615144654K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemFEB2024-12-02
2801311615144654K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemFEB2024-12-02
2810371896316314K242839Safe Secure Sterilization Pouches and RollsFRG2024-10-16
2800271044086383K242189CELERITY HP Indicator Tape (PCC077)JOJ2024-08-20
2810371044086383K242189CELERITY HP Indicator Tape (PCC077)JOJ2024-08-20
2800271964043067K240760CELERITY HP Indicator TapeJOJ2024-04-10
2810371964043067K240760CELERITY HP Indicator TapeJOJ2024-04-10
2810371545124453K233682VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATEOVY2023-12-15
2800271657286677K233681ConFirm 20 Minute IncubatorFRC2023-12-15
2801111586560591K233065V-PRO maX 2 Low Temperature Sterilization SystemMLR2023-10-20
2801311586560591K233065V-PRO maX 2 Low Temperature Sterilization SystemMLR2023-10-20
2798331793111617K232918enspire 300 Series Automated Endoscope ReprocessorNZA2023-10-03
2800071793111617K232918enspire 300 Series Automated Endoscope ReprocessorNZA2023-10-03
2800271793111617K232918enspire 300 Series Automated Endoscope ReprocessorNZA2023-10-03
2801311793111617K232918enspire 300 Series Automated Endoscope ReprocessorNZA2023-10-03
2809141793111617K232918enspire 300 Series Automated Endoscope ReprocessorNZA2023-10-03
2800271585242975K232914SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)MED2023-10-03
2801111585242975K232914SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)MED2023-10-03
2801311585242975K232914SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)MED2023-10-03
2809141585242975K232914SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)MED2023-10-03
2810371935582015K231746VERIFY Spore Test Strip for S40 Sterilant ConcentrateOVY2023-09-11
2810371685760481K231501PRO-LITE Sterilization TrayKCT2023-08-07
2810371413168761K231500Vis-U-All Low Temperature Sterilization PouchesFRG2023-08-07
2810371067230060K231490Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological IndicatorFRC2023-08-07
2800271268856108K231488Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator TapeJOJ2023-08-07
2810371268856108K231488Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator TapeJOJ2023-08-07
2800271304213000K230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemFEB2023-06-30
2801111304213000K230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemFEB2023-06-30
2801311304213000K230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemFEB2023-06-30
2800271195992534K230582SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED2023-03-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MED802026-04-08
FRC512026-04-08
JOJ422025-04-25
MLR392023-10-20
KCT212023-08-07
NZA202023-10-03
FRG152024-10-16
GEI152021-10-25
GCJ152016-02-01
DXC102021-03-04
FEB72024-12-02
NEU72017-04-27
NVE52022-09-30
MQV52015-11-10
GZT52009-03-18
FRN52005-03-24
OVY42023-12-15
FYD42014-03-03
FST42012-11-01
FQO42009-03-20
FTL32018-02-01
KWQ32012-12-07
LGZ32011-07-29
HET31999-02-18
HTD31998-06-24
HRX31997-10-24
FSM31994-11-22
SHM22026-05-01
SDC22024-11-12
PQK22019-10-17
HFI22015-12-23
HWC22015-07-24
MIX22015-04-06
KKX22010-11-09
CAC22010-10-05
FPA22003-12-04
EIA22003-10-30
GXZ22001-03-19
LKK22000-07-21
DWJ12020-06-13

NDC#

PMN#

200 records. Showing 1-40. Next

Applications#

GUDID#

200 records. Showing 1-40. Next