FDA.reportPublic FDA data

Sterinc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10184701018470Sterigenics U.S., LLC1N2026-01-012971 Olympic Industrial Dr SE Ste 116 Atlanta GA US 30339
10368361036836Sterigenics U.S., LLC1N2026-01-011148 Porter Ave Haw River NC US 27258
10379781037978STERIMED, LLC.1Y2026-01-0195 CHASTAIN RD. Suite 201 Kennesaw GA US 30144
10435721043572STERIS CORPORATION1N2026-01-012720 GUNTER PARK DRIVE EAST MONTGOMERY AL US 36109
10487351048735STERILIZATION SERVICES OF GEORGIA, INC.1N2026-01-016005 BOATROCK BLVD. ATLANTA GA US 30336
10533061053306STERIMED, Inc.1N2026-01-012266 Volvo Car Dr Suite 100 Ridgeville SC US 29472
10548111000114185Sterigenics U.S. LLC1N2026-01-01502 Prairie Mine Rd MULBERRY FL US 33860
10585841000219637Sterigenics US LLC1N2026-01-0110811 Withers Cove Park Drive Charlotte NC US 28278
10611241000512168Sterigenics U.S., LLC1N2026-01-0110821 Withers Cove Park Dr Charlotte NC US 28278
11231371000123180STERILIZATION SERVICES OF VIRGINIA1N2026-01-015670-5678 EASTPORT BLVD. RICHMOND VA US 23231
13196391000138054Sterigenics U.S., LLC1N2026-01-0184 Park Rd Queensbury NY US 12804
14192261419226STEREO OPTICAL COMPANY LLC1N2026-01-018600 W Catalpa Ave Ste 703 CHICAGO IL US 60656
14200321420032Sterigenics U.S., LLC1N2026-01-01711 Cooper Ct Schaumburg IL US 60173
14225981000220280Sterling Medical Products1N2026-01-01401 MARKET ST. Prophetstown IL US 61277
14236623000215273Sterigenics US LLC1N2026-01-011003 Lakeside Drive Gurnee IL US 60031
15265311526531STERIS Corporation1N2026-01-0117820 ENGLEWOOD DR. CLEVELAND OH US 44130
15265341526534Sterigenics US, LLC1N2026-01-01305 Enterprise Dr Lewis Center OH US 43035
15278211527821STERIS CORPORATION1Y2026-01-015960 Heisley Road Mentor OH US 44060
16471491000306139Steritec Services, LLC1N2026-01-011705 ENTERPRISE ST. ATHENS TX US 75751
16495183001236277Sterigenics US LLC1N2026-01-013125 Wichita Court Fort Worth TX US 76140
17216761721676Sterigenics U.S., LLC1N2026-01-015725 Harold Gatty Dr Salt Lake City UT US 84116
17216861721686Sterigenics U.S., LLC1N2026-01-012400 Airport Rd Santa Teresa NM US 88008
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

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
M588001004115110Cardiodrive System - The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.13146786100info@stereotaxis.com
M588001004115120Cardiodrive System - The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.13146786100info@stereotaxis.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1469231949820517P020014ESSURE SYSTEMHHS2002-11-04
1038471831049149P020012ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLERLMH2006-10-27
1038441305387897K993138BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KITKNT1999-10-20
3298981455740309K991928MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORSGCJ1999-06-25
3298981541781291K991589FLEXIBLE VASCULAR CLAMP, VERSION 2DXC1999-05-18
1469081264859005K990707MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERSDQY1999-03-22
1754951624084224K990671DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPEHOZ1999-05-10
3298931816585772K983299ALLEGIANCE GENESIS CONTAINER SYSTEMFRG2000-08-04
3298981816585772K983299ALLEGIANCE GENESIS CONTAINER SYSTEMFRG2000-08-04
1038441549050430K982894MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KITKNT1998-09-11
3298981911533300K982465DEROYAL INDUSTRIES, INC. DEFOGGEROCT1998-08-11
3298981180304966K981956DEGANIA SILICONE IDENTI LOOPSDXC1998-07-09
1469081356020224K981198MEDTRONIC ZUMA GUIDING CATHETERDQY1998-08-07
3298981265780500K974769COSGROVE CLAMPDXC1998-06-12
3298981266040206K974595CUSHING BAYONET, INSULATED BIPOLAR FORCEPHTD1998-06-24
3298981176002914K974594SEMKIN BIPOLAR FORCEPHTD1998-06-24
3298981380044464K974593SEMKIN INSULATED BIPOLAR FORCEPHTD1998-06-24
1178471107166906K974028STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBINGMKO1998-01-21
1178471921352239K972774GAS PLASMA STERILIZATIONJWH1999-05-05
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
1178472037476326K963109HERITAGE HIP SYSTEMJDI1997-01-09
1467871509636781K962907SKINNY,FRANSEEN,WESCOTT NEEDLESKNW1996-10-23
3298931801508644K962545DENTAL, MEDICAL INSTRUMENT CASES & CASSETTEKCT1997-03-07
1178471008936520K962196NEXGEN KNEE PROSTHESIS & LEGACY KNEE PROSTHESIS W/CO-NIDIUM SURFACE HARDENING PROCESSJWH1996-08-23
1178471061789545K961378DELTA HIP PROSTHESISLWJ1996-10-08
1178471862611094K960626MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST)JDI1996-04-18
1038431475684294K96050918 GAUGE TRU-CUT BIOPSY NEEDLEKNW1996-04-04
1178471822478407K960278COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENTJDI1996-07-25
1469171575218025K960248GENERAL PROCEDURE KITFMF1996-04-12
1178471171789193K954744ZCH ALPHA SYSTEMJDI1996-01-23
1178471147107911K954698TRILOGY ACETABULAR COMPONENT 7MM OFFSETLPH1996-01-17
3298981713648361K951413FOGARTY-HYDRAGRIP SURGICAL CLAMPSDXC1995-08-18
1469171550205863K945484PIDURAL STEROID SYSTEMCAZ1995-06-02
3298981074094976K944025SURGICAL INSTRUMENT TRAYFSM1994-11-22
1178471544452653K941213SONGER CABLE SYSTEMJDQ1994-04-19
1178471582987960K934381APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERTJWH1995-02-08
1038431753360744K932553DISPOSABLE SUTURE PLACEMENT SYSTEMGCJ1994-05-12
3298981862443917K931340GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTORGCS1993-07-01
759081549099336K931202STERILIZATION WRAP-STERISHEETFRG1993-12-16
1178471217833418K930831MG II POROUS KNEE SYSTEM FEMORAL COMPONENTSJWH1993-11-16
3298981908634724K930667REUSABLE LAPAROSCOPIC INSTRUMENTSGCJ1994-05-16
3298982023137704K930666REUSABLE 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
1178471364783794K922071ZIMMER ANATOMIC HIP SYSTEMLPH1994-02-22
3298981118397587K914426ENTREE NEEDLEFHO1991-11-27
1178472070901083K913649MODULAR CALCAR REPLACEMENTJDI1991-11-13
3298981257081863K913500CHERRY SPONGEGCJ1991-09-25
1178471499040684K911572MG II POROUS COBAL T-CHROME FEMORAL COMPONENTJWH1991-07-01
1038471899027654K911109OPHTA SIL (R), LACHRYMAL INTUBATION SETSOKS1991-05-01
2831621040354760K905816ORTHOVISION TABLEJEB1991-03-06
3298981013915138K904173INSULATED ELECTRODES AND LAPAROSCOPIC PROBICSHET1990-12-10
3298981469837627K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFST1990-04-23
1469081067383154K900640MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDUDTR1990-04-20
3298981352298803K895395V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTORGZT1989-10-19
1469172011091690K884913MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)DXT1989-04-18
1178471661905114K883665COONRAD III TOTAL ELBOWJDC1989-02-03
2831621516366938K882660GENERAL SURGICAL TABLE AND ACCESSORIESFQO1988-07-25
1178471792159478K882494ELAN-E DISPOSALBE DRAPEKKX1988-07-08
1178471646127478K872019BI-ARTICULAR II HIP DEVICEKWY1987-07-21
1886821676914602K853044STERICOVERIZI1985-11-01
3298932033528204K844652C.A.S.E. CONTAINERFSM1984-12-12
3298982033528204K844652C.A.S.E. CONTAINERFSM1984-12-12
1178471390091176K834432ANTHRO-MODULAR TOTAL KNEEJWH1984-04-11
1178471084200684K833991BIPOLAR HIP DEVICEKWY1984-01-30
1178471132147155K830196CORSTREN COMPRESSION TUBE & PLATEKTT1983-03-25
1178471647168135K830121INSALL/BURSTEIN FIBER METAL CONDYLAR/KNEJWH1983-04-26
1178471667782959K821893ZIMMER METAL BACKED ACETABULAR CUPJDI1982-09-14
1178471856221017K812182MIAMI, PROTRUSIO RINGJDI1981-08-18
3298981494215198K811820BIPOLAR COAGULATING FORCEPSGEI1981-07-28
1178471985750994K811416MOORE HIP PROSTHESIS, PMMA COATEDKWL1981-08-12
1038431195778969K800823QUICK FILLDXT1980-04-29
1178471618846409K800142FUSON BONE PLUG, RADIOPAQUEJDS1980-02-19
1178471912245158K790987ZIMMER R TOTAL SHOULDER IIKWT1979-06-22
2801111912387486K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED2026-04-08
2801111615144654K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemFEB2024-12-02
2801111586560591K233065V-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
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
2801111304213000K230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemFEB2023-06-30
2801111195992534K230582SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED2023-03-28
2798331931979632K230560enspire 300 Series Automated Endoscope Reprocessor SystemNZA2023-07-21
2800071931979632K230560enspire 300 Series Automated Endoscope Reprocessor SystemNZA2023-07-21
2801111730977769K222615SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant ConcentrateMED2022-09-28
2801111551019459K222093V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization SystemMLR2022-09-09
3298981863850072K213386Titan Manufacturing Bipolar ForcepsGEI2021-10-25
2801111505182030K211607SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant ConcentrateMED2021-09-07
2801111075709618K210737SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant ConcentrateMED2021-05-12
3298981428814480K210324V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186DXC2021-03-04
2831621780933814K200446STERIS Patient Warming SystemDWJ2020-06-13
2801111762161137K192929SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED2019-12-10
2801111673534027K191343SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900MED2019-09-05
2801111882183193K190917V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization SystemsMLR2019-05-09
2801111856743876K190104SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing SystemMED2019-03-22
2801111085644974K190103V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization SystemMLR2019-04-05
1178471028935829K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadLPH2019-11-05
2801111054680592K182827SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900MED2019-01-31
2801111053303879K182568V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization SystemMLR2019-01-03
1469171033676125K181772NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)GAT2018-08-01
1038471283940713K181591Fixated Asfora BULLET CAGE® (FABC)MAX2018-09-26
1754951375024802K181578DemeTECH PTFE Nonabsorbable Surgical SutureNBY2018-10-11
1038431567954022K180986XableCath Support Catheter Product FamilyDQY2018-05-15
1469171245942970K180919GORE Tri-Lumen CatheterDQY2018-10-05
1469171857028970K180531NovoStitch Pro Meniscal Repair SystemGAT2018-03-29
1469171916673646K180412Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and CanisterQEW2018-05-15
2801111590452196K180342SYSTEM 1E Liquid Chemical Sterilant Processing SystemMED2018-04-04
1469171098660022K180105Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump CanisterQEW2018-03-08
1469171572950557K180008Penumbra SystemNRY2018-06-20
2801111129258706K173256System 1 endo Liquid Chemical Sterilant Processing SystemMED2018-03-02
2801111612613930K172754V-PRO maX 2 Low Temperature Sterilization SystemMLR2018-02-09
2801111927834612K172319AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization SystemMLR2018-01-18
31521500970960K171370IMAGEnet 6 Ophthalmic Data SystemNFJ2017-11-01
2801111115511414K170956SYSTEM 1E Liquid Chemical Sterilant Processing SystemMED2017-09-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MED232026-04-08
MLR192023-10-20
GEI172021-10-25
GCJ132016-02-01
DQY112018-10-05
KCT102016-03-21
DXC72021-03-04
DWF72013-03-22
FRG72012-08-24
KKX72010-11-09
JWH71999-05-05
JDI71997-01-09
LPH52019-11-05
GZT52009-03-18
HWC52006-06-12
NZA42023-10-03
DXT42011-12-15
FQO42009-03-20
MAX32018-09-26
DYB32014-03-06
FYD32014-03-03
LGZ32011-07-29
KNT32004-12-10
HTD31998-06-24
FSM31994-11-22
SHM22026-05-01
FEB22024-12-02
GAT22018-08-01
QEW22018-05-15
HFI22015-12-23
KDI22014-02-04
OVE22014-01-16
CAZ22012-08-02
BTR22012-05-11
FPA22012-05-04
JOJ22011-04-15
FYA22010-12-23
FST22010-03-17
FMF22007-09-21
JCT22007-09-19

NDC#

Doxycycline

Steriscience Specialties Private Limited

Doxycycline

Midazolam

Steriscience Specialties Private Limited

midazolam hydrochloride

Midazolam

Steriscience Specialties Private Limited

midazolam hydrochloride

Midazolam

Steriscience Specialties Private Limited

midazolam hydrochloride

Midazolam

Steriscience Specialties Private Limited

midazolam hydrochloride

Midazolam

Steriscience Specialties Private Limited

midazolam hydrochloride

Midazolam

Steriscience Specialties Private Limited

midazolam hydrochloride

Midazolam

Steriscience Specialties Private Limited

midazolam hydrochloride

FOCINVEZ

Steriscience Specialties Private Limited

FOSAPREPITANT DIMEGLUMINE

PMA#

DYNASOL 4

1991-06-20

STERIDYNE LABORATORIES, INC.

PMN#

200 records. Showing 1-40. Next

Applications#

219492

STERISCIENCE PTE. LIMITED

GUDID#

GenesisX - Stereotaxis GenesisX RMN with Navigant™ Workstation (NWS) and Cardiodrive® System (GenesisX) is an interventional workstation for the intravascular navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) using computer-controlled permanent magnets to orient or steer the tip of a magnetic device, and remotely advance and retract only compatible magnetic electrophysiology (EP) catheters inside the patient’s heart. GenesisX incorporates software that determines the direction the magnetic field should be applied based on physician interaction with the user interface devices.

Stereotaxis, Inc.

2026-01-09

Vdrive Drape - """The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). """

Stereotaxis, Inc.

2016-08-01

Vdrive System - """The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). """

Stereotaxis, Inc.

2016-08-01

Vdrive System - """The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). """

Stereotaxis, Inc.

2016-08-01

80 records. Showing 1-40. Next