FDA.report

STERIS CORPORATION

FDA Registration(s)

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
30002512743000251274STERIS Corporation1N2026-01-016515 HOPKINS RD. Mentor OH US 44060
30039502073003950207STERIS Corporation1Y2026-01-016100 Heisley Rd Mentor OH US 44060
30040809203004080920STERIS CORPORATION1N2026-01-019325 Pinecone Drive Mentor OH US 44060
30074128093007412809STERIS Corporation1N2026-01-0111457 MELROSE AVE FRANKLIN PARK IL US 60131
30087762873008776287STERIS Corporation1N2026-01-01503 Canal Blvd ad Richmond CA US 94804
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 DO 00000
10435721043572STERIS CORPORATION1N2020-04-252720 GUNTER PARK DRIVE EAST MONTGOMERY AL US 36109
15278211527821STERIS Corporation1Y2020-04-255960 Heisley Rd Mentor OH US 44060
19334431000510740STERIS CORPORATION1Y2020-04-258525 Page Ave Breckenridge Hills MO US 63114
19375311937531STERIS CORPORATION1N2020-04-257501 Page Ave Saint Louis MO US 63133
30002512743000251274STERIS Corporation1N2020-04-256515 HOPKINS RD. Mentor OH US 44060
30039502073003950207STERIS Corporation1N2020-04-256100 Heisley Rd Mentor OH US 44060
30040809203004080920STERIS CORPORATION1N2020-04-259325 Pinecone Dr MENTOR OH US 44060
30074128093007412809STERIS Corporation1N2020-04-2511457 MELROSE AVE FRANKLIN PARK IL US 60131

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3298981455740309K991928MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORSGCJ1999-06-25
3298981541781291K991589FLEXIBLE VASCULAR CLAMP, VERSION 2DXC1999-05-18
29881675950718K991167STERIS SMOKE EVACUATION SYSTEMFYD1999-06-03
3298981816585772K983299ALLEGIANCE GENESIS CONTAINER SYSTEMFRG2000-08-04
3298931816585772K983299ALLEGIANCE GENESIS CONTAINER SYSTEMFRG2000-08-04
3298981911533300K982465DEROYAL INDUSTRIES, INC. DEFOGGEROCT1998-08-11
3298981180304966K981956DEGANIA SILICONE IDENTI LOOPSDXC1998-07-09
3298981265780500K974769COSGROVE CLAMPDXC1998-06-12
3298981266040206K974595CUSHING BAYONET, INSULATED BIPOLAR FORCEPHTD1998-06-24
3298981176002914K974594SEMKIN BIPOLAR FORCEPHTD1998-06-24
3298981380044464K974593SEMKIN INSULATED BIPOLAR FORCEPHTD1998-06-24
3298981686607091K971540AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORDGEI1997-08-14
2831621880384164K971307AMSCO SURGICAL TABLEFQO1997-06-27
29882062996561K971307AMSCO SURGICAL TABLEFQO1997-06-27
3298981282494310K964402VERSATRAC (TM) LUMBAR RETRACTOR SYSTEMGZT1997-01-23
3298931282494310K964402VERSATRAC (TM) LUMBAR RETRACTOR SYSTEMGZT1997-01-23
3298931801508644K962545DENTAL, MEDICAL INSTRUMENT CASES & CASSETTEKCT1997-03-07
3298981713648361K951413FOGARTY-HYDRAGRIP SURGICAL CLAMPSDXC1995-08-18
3298981074094976K944025SURGICAL INSTRUMENT TRAYFSM1994-11-22
29881039682832K943288AMSCO SQ240 SURGICAL LIGHTFSY1994-10-17
29881141448976K935356CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLESFWW1994-03-23
29831471107223K931872THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZERFLF1994-02-07
29831471107223K931872THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZERFLF1994-02-07
29821471107223K931872THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZERFLF1994-02-07
3298981862443917K931340GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTORGCS1993-07-01
3298981908634724K930667REUSABLE LAPAROSCOPIC INSTRUMENTSGCJ1994-05-16
3298982023137704K930666REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERYGEI1994-05-19
29881014136135K930493QUANTUM 3080 SURGICAL TABLEFQO1993-06-22
2831621359285171K930493QUANTUM 3080 SURGICAL TABLEFQO1993-06-22
2831621014558824K930041VICROSAFE 6 AND VICROSAFE 12FYD1993-11-03
29881626161142K930041VICROSAFE 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
29881389788241K924732PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEMFYD1993-09-13
3298981118397587K914426ENTREE NEEDLEFHO1991-11-27
3298981257081863K913500CHERRY SPONGEGCJ1991-09-25
2831621040354760K905816ORTHOVISION TABLEJEB1991-03-06
29881272452122K905816ORTHOVISION TABLEJEB1991-03-06
3298981013915138K904173INSULATED ELECTRODES AND LAPAROSCOPIC PROBICSHET1990-12-10
3298981469837627K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFST1990-04-23
2800271024116940K897045BOWIE-DICK TEST CARD CATALOG NUMBER 008018JOJ1990-02-15
29961165270470K897045BOWIE-DICK TEST CARD CATALOG NUMBER 008018JOJ1990-02-15
29851165270470K897045BOWIE-DICK TEST CARD CATALOG NUMBER 008018JOJ1990-02-15
29881650621844K896674AMSCO QUANTUM LIGHTFSY1990-01-03
29961509453634K895910STEAMLINEJOJ1990-08-22
3298981352298803K895395V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTORGZT1989-10-19
29961194529859K890760STRIP, STERILIZATION INDICATOR, E.O. GASJOJ1989-08-07
2831621516366938K882660GENERAL SURGICAL TABLE AND ACCESSORIESFQO1988-07-25
29881775850501K882660GENERAL SURGICAL TABLE AND ACCESSORIESFQO1988-07-25
29881916835669K880198GEMINI SURGICAL LIGHTFSS1988-02-10
29951723648452K875280STERIS SYSTEM 1 PROCESSOR AND 20 STERILANTMED1988-09-13
2810371342172797K863122ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.FRC1986-12-17
29961702357330K863122ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.FRC1986-12-17
29961651010457K855101ASSERT TM BIOLOGICAL/CHEMICAL INDICATORFRC1986-07-17
2810372017740895K855101ASSERT TM BIOLOGICAL/CHEMICAL INDICATORFRC1986-07-17
29881039292072K854922AMSCO POLARIS SLFSY1986-01-24
29961144642561K854902SURGICOT STEAM TEST PACKFRC1986-05-20
2810371352582688K854902SURGICOT STEAM TEST PACKFRC1986-05-20
29961292479307K854631ASSERT EO BIOLOGICAL TEST PACKFRC1986-05-27
29961226186669K850289MONARCH STERILIZATION CONTAINER SYSTEMFRG1985-08-15
29961691578791K850143SPORDEX CULTURE MEDIAJSC1985-03-05
3298982033528204K844652C.A.S.E. CONTAINERFSM1984-12-12
3298932033528204K844652C.A.S.E. CONTAINERFSM1984-12-12
29961295845386K844512DART DAILY AIR REMOVAL TESTJOJ1985-03-21
29851295845386K844512DART DAILY AIR REMOVAL TESTJOJ1985-03-21
2800271615941978K844512DART DAILY AIR REMOVAL TESTJOJ1985-03-21
29881954759973K831309DELIVERY 4 TABLEKNC1983-06-15
29881110346812K823772AMSCO ORTHOGRAPHIC 2 TABLEBWN1983-01-14
29881067924764K823360SURGICAL LIGHTFTD1982-12-03
3298981494215198K811820BIPOLAR COAGULATING FORCEPSGEI1981-07-28
2810371610914726K800029SURGICOT 2 INDICATOR SYSTEMFRC1980-03-12
29962057739623K800029SURGICOT 2 INDICATOR SYSTEMFRC1980-03-12
29961458202445K771846SUOGIPEEL PACKAGING SYSTEMFRG1977-10-13
2810371385890581K260766Celerity 5 HP Biological Indicator (LCB052)FRC2026-04-08
2801311912387486K251666SYSTEM 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
2800271912387486K251666SYSTEM 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
2800271048865730K243876VERIFY STEAM Integrating IndicatorJOJ2025-04-25
2800091048865730K243876VERIFY STEAM Integrating IndicatorJOJ2025-04-25
2801311615144654K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemFEB2024-12-02
2800271615144654K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemFEB2024-12-02
2801111615144654K243433enspire 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
2810371964043067K240760CELERITY HP Indicator TapeJOJ2024-04-10
2800271964043067K240760CELERITY HP Indicator TapeJOJ2024-04-10
2810371545124453K233682VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATEOVY2023-12-15
2800271657286677K233681ConFirm 20 Minute IncubatorFRC2023-12-15
2801311586560591K233065V-PRO maX 2 Low Temperature Sterilization SystemMLR2023-10-20
2801111586560591K233065V-PRO maX 2 Low Temperature Sterilization SystemMLR2023-10-20
2801311793111617K232918enspire 300 Series Automated Endoscope ReprocessorNZA2023-10-03
2800271793111617K232918enspire 300 Series Automated Endoscope ReprocessorNZA2023-10-03
2800071793111617K232918enspire 300 Series Automated Endoscope ReprocessorNZA2023-10-03
2798331793111617K232918enspire 300 Series Automated Endoscope ReprocessorNZA2023-10-03
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
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
2797981643186663K231878Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101FGB2023-07-25
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
2801311304213000K230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemFEB2023-06-30
2800271304213000K230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemFEB2023-06-30
2801111304213000K230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemFEB2023-06-30
2801311195992534K230582SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED2023-03-28
2801111195992534K230582SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED2023-03-28
2800271195992534K230582SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED2023-03-28
2801311931979632K230560enspire 300 Series Automated Endoscope Reprocessor SystemNZA2023-07-21
2798331931979632K230560enspire 300 Series Automated Endoscope Reprocessor SystemNZA2023-07-21
2800071931979632K230560enspire 300 Series Automated Endoscope Reprocessor SystemNZA2023-07-21
2800271931979632K230560enspire 300 Series Automated Endoscope Reprocessor SystemNZA2023-07-21
2810371872953483K223717Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge PackFRC2023-06-15

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MED922026-04-08
FRC902026-04-08
JOJ842025-04-25
MLR712023-10-20
KCT312023-08-07
FRG242024-10-16
NZA152023-10-03
GCJ102016-02-01
FQO82009-03-20
GEI72021-10-25
FYD72014-03-03
FEB62024-12-02
OVY62023-12-15
DXC62021-03-04
LGZ62011-07-29
OWP52018-06-13
GZT52009-03-18
FSY52007-10-05
FST42010-03-17
FGB32023-07-25
FTD32001-12-13
HTD31998-06-24
FSM31994-11-22
FLF31994-02-07
SDC22024-11-12
HFI22015-12-23
HET21994-08-24
JEB21991-03-06
DWJ12020-06-13
NIH12014-08-27
HES12014-04-21
FTA12014-01-07
DWP12010-08-31
LWH12010-08-12
HCZ12009-12-03
HAE12008-08-08
HBL12000-08-29
OCT11998-08-11
FWW11994-03-23
GCS11993-07-01

NDC

PMN

173 records. Showing 1-40. Next

GUDID

Amsco

2026-02-13

STERIS CORPORATION

Amsco

2026-02-13

STERIS CORPORATION

Amsco

2026-02-13

STERIS CORPORATION

Amsco

2026-02-13

STERIS CORPORATION

Amsco

2026-02-13

STERIS CORPORATION

Amsco

2026-02-13

STERIS CORPORATION

Amsco

2026-02-13

STERIS CORPORATION

Amsco

2026-02-13

STERIS CORPORATION

Amsco

2026-02-13

STERIS CORPORATION

Amsco

2026-02-13

STERIS CORPORATION

NA

2026-02-13

STERIS CORPORATION

NA

2026-02-13

STERIS CORPORATION

NA

2026-02-13

STERIS CORPORATION

NA

2026-02-13

STERIS CORPORATION

NA

2026-02-13

STERIS CORPORATION

NA

2026-02-13

STERIS CORPORATION

NA

2026-02-13

STERIS CORPORATION

NA

2026-02-13

STERIS CORPORATION

NA

2026-02-13

STERIS CORPORATION

NA

2026-02-13

STERIS CORPORATION

NA

2026-01-26

STERIS CORPORATION

NA

2026-01-26

STERIS CORPORATION

ALYON

2026-01-05

STERIS CORPORATION

NA

2025-12-16

STERIS CORPORATION

HexaLux

2025-05-05

STERIS CORPORATION

HexaLux

2025-05-05

STERIS CORPORATION

HexaLux

2025-05-05

STERIS CORPORATION

HexaLux

2025-05-05

STERIS CORPORATION

NA

2025-05-05

STERIS CORPORATION

Clamp

2025-05-05

STERIS CORPORATION

HexaLux

2025-05-05

STERIS CORPORATION

NA

2025-04-30

STERIS CORPORATION

200 records. Showing 1-40. Next