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Data / Medical devices / United States / STERIS Corporation

STERIS Corporation: FDA-registered device maker in Saint Louis, MO, United States, 53 510(k) clearances

STERIS Corporation is registered with the FDA (registration 1923569) in Saint Louis, MO, United States. It lists 212 device types. The FDA files 53 510(k) clearances under its listings, the newest dated October 25, 2021. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch STERIS Corporation
FDA registration number
1923569
Address
5 Sunnen DR., Saint Louis, MO, United States, 63143
Owner or operator
STERIS (10091086)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed
June 27, 2024
Registered through
2027
Brand names listed
Affinity Forceps (ST-RR), Affinity Metric Ruler (ST-RR), Affinity RASP (ST-CFE,SD, WM-FE,RR), Affinity Scissors (ST-RR, WM-FE,RR), Affinity Uterine Packer (ST-SD,CFE, WM-FE,RR), Ergonomic Take Apart (ST-MF, RR, WM-FE,RR), Genesis Container Systems (CL-MF,RR, ST-SD), Genesis Container Systems (CL-RR, ST-SD, CFE) and more

Devices it lists

DeviceProduct codeClassRoleSource
Anoscope And AccessoriesFER2Specification developeraccessdata.fda.gov
Anti Fog Solution And Accessories, EndoscopyOCT2Complaint file establishmentaccessdata.fda.gov
Applicator, EntKCJ1Manufactureraccessdata.fda.gov
AwlHWJ1Complaint file establishmentaccessdata.fda.gov
Bar, PreformedEHO1Complaint file establishmentaccessdata.fda.gov
Basin, EmesisFNY1Complaint file establishmentaccessdata.fda.gov
Biopsy NeedleFCG2Complaint file establishmentaccessdata.fda.gov
Bit, DrillHTW1Complaint file establishmentaccessdata.fda.gov
Block, Cutting, Ent, Non-SterileNNR1Manufactureraccessdata.fda.gov
Bougie, UrologicalFAX1Manufactureraccessdata.fda.gov
CaliperKTZ1Manufactureraccessdata.fda.gov
Caliper, OphthalmicHOE1Complaint file establishment, Specification developeraccessdata.fda.gov
Cannula, EarJYC1Complaint file establishment, Specification developeraccessdata.fda.gov
Cannula, OphthalmicHMX1Manufactureraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Manufactureraccessdata.fda.gov
Cannula, VentricularHCD1Manufactureraccessdata.fda.gov
Cardiovascular Surgical Instruments TrayOFA1Manufactureraccessdata.fda.gov
Carrier, LigatureGEJ1Manufactureraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Manufactureraccessdata.fda.gov
Catheter, Urethrographic, MaleFGI2Complaint file establishment, Specification developeraccessdata.fda.gov
Chisel, Middle-EarJYE1Complaint file establishment, Specification developeraccessdata.fda.gov
Chisel, NasalKAN1Manufactureraccessdata.fda.gov
Chisel, Osteotome, SurgicalEMM1Specification developeraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Manufactureraccessdata.fda.gov
ClampHXD1Specification developeraccessdata.fda.gov
Clamp, Non-ElectricalFFN1Specification developeraccessdata.fda.gov
Clamp, PenileFHA1Manufactureraccessdata.fda.gov
Clamp, VascularDXC2Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Coagulator, Culdoscopic (And Accessories)HFI2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Complaint file establishmentaccessdata.fda.gov
CorkscrewHWI1Complaint file establishmentaccessdata.fda.gov
Crimper, Wire, Ent, Non-SterileNNN1Complaint file establishmentaccessdata.fda.gov
CuretteHTF1Complaint file establishment, Specification developeraccessdata.fda.gov
Curette, AdenoidKBJ1Specification developeraccessdata.fda.gov
Curette, EarJYG1Complaint file establishment, Specification developeraccessdata.fda.gov
Curette, NasalKAP1Specification developeraccessdata.fda.gov
Curette, OphthalmicHNZ1Manufactureraccessdata.fda.gov
Curette, Surgical, DentalEMK1Specification developeraccessdata.fda.gov
Curette, Surgical, General UseFZS1Manufactureraccessdata.fda.gov
Curette, UterineHCY1Complaint file establishmentaccessdata.fda.gov
Cutter, SurgicalFZT1Repackager or relabeleraccessdata.fda.gov
Cutter, WireHXZ1Complaint file establishment, Specification developeraccessdata.fda.gov
CystotomeHNY1Complaint file establishmentaccessdata.fda.gov
Depressor, Metal Tongue, SurgicalKBL1Manufactureraccessdata.fda.gov
Depressor, OrbitalHNX1Complaint file establishmentaccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Complaint file establishmentaccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Manufacturer, Specification developeraccessdata.fda.gov
Dilator, LachrymalHNW1Specification developeraccessdata.fda.gov
Dilator, TrachealKCG1Specification developeraccessdata.fda.gov
Dilator, UrethralKOE2Specification developeraccessdata.fda.gov
Dilator, Vessel, SurgicalDWP2Complaint file establishment, Manufactureraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dissector, TonsilKBM1Manufactureraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Manual)HBG2Specification developeraccessdata.fda.gov
Ear, Nose, And Throat Surgical TrayOGR1Manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Elevator, EntKAD1Manufactureraccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Complaint file establishmentaccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Manufactureraccessdata.fda.gov
Endoscope, Battery-Powered And AccessoriesGCS2Manufactureraccessdata.fda.gov
Excavator, EarJYH1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
File, Bone, SurgicalEMI1Complaint file establishmentaccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Complaint file establishment, Specification developeraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Manufacturer, Specification developeraccessdata.fda.gov
Forceps, EntKAE1Repackager or relabeleraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Forceps, ObstetricalHDA2Specification developeraccessdata.fda.gov
Forceps, OphthalmicHNR1Specification developeraccessdata.fda.gov
Forceps, Surgical, GynecologicalHCZ2Complaint file establishment, Specification developeraccessdata.fda.gov
Forceps, Tooth Extractor, SurgicalEMG1Complaint file establishmentaccessdata.fda.gov
Forceps, Tube IntroductionBWB1Complaint file establishmentaccessdata.fda.gov
Forceps, Wire HoldingHYA1Manufactureraccessdata.fda.gov
Gag, MouthKBN1Specification developeraccessdata.fda.gov
Gauge, DepthHTJ1Manufactureraccessdata.fda.gov
Gauge, MeasuringJYJ1Complaint file establishment, Specification developeraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Complaint file establishmentaccessdata.fda.gov
General Surgery TrayLRO2Complaint file establishment, Specification developeraccessdata.fda.gov
Gouge, Surgical, General & Plastic SurgeryGDH1Manufactureraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Complaint file establishmentaccessdata.fda.gov
Hammer, SurgicalFZY1Complaint file establishmentaccessdata.fda.gov
Handle, ScalpelGDZ1Manufactureraccessdata.fda.gov
HemostatHRQ1Complaint file establishmentaccessdata.fda.gov
Holder, Head, Neurosurgical (Skull Clamp)HBL2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Manufacturer, Specification developeraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Specification developeraccessdata.fda.gov
Hook, BoneKIK1Manufactureraccessdata.fda.gov
Hook, Fibroid, GynecologicalHDE1Specification developeraccessdata.fda.gov
Hook, Microsurgical EarJYL1Manufactureraccessdata.fda.gov
Hook, OphthalmicHNQ1Manufactureraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Manufactureraccessdata.fda.gov
Hook, TrachealKCH1Manufactureraccessdata.fda.gov
ImpactorHWA1Manufactureraccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Complaint file establishmentaccessdata.fda.gov
Instrument, Cast Application/Removal, ManualLGG1Repackager or relabeleraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Complaint file establishment, Specification developeraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Specification developeraccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Complaint file establishmentaccessdata.fda.gov
Instrument, Manual, General Obstetric-GynecologicKOH1Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufactureraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Shunt System ImplantationGYK1Manufactureraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Manufacturer, Specification developeraccessdata.fda.gov
Instruments, Dental HandDZN1Complaint file establishmentaccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)HES2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Knife, AmputationGDN1Complaint file establishmentaccessdata.fda.gov
Knife, EarJYO1Manufactureraccessdata.fda.gov
Knife, EntKTG1Specification developeraccessdata.fda.gov
Knife, NasalKAS1Manufactureraccessdata.fda.gov
Knife, OphthalmicHNN1Manufacturer, Specification developeraccessdata.fda.gov
Knife, OrthopedicHTS1Manufactureraccessdata.fda.gov
Knife, SurgicalEMF1Manufactureraccessdata.fda.gov
Knife, TonsilKBQ1Specification developeraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Light, Surgical, FiberopticFST2Repackager or relabeleraccessdata.fda.gov
Loop, WireJYQ1Manufactureraccessdata.fda.gov
MalletHXL1Specification developeraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Manufactureraccessdata.fda.gov
Marker, OcularHMR1Complaint file establishmentaccessdata.fda.gov
Marker, SkinFZZ1Specification developeraccessdata.fda.gov
Mirror, EntKAI1Complaint file establishmentaccessdata.fda.gov
Mobilizer, EntKAJ1Manufactureraccessdata.fda.gov
Needle, Gastro-UrologyFHR1Complaint file establishmentaccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Manufactureraccessdata.fda.gov
Needle, Neurosurgical SutureHAS1Complaint file establishment, Specification developeraccessdata.fda.gov
Needle, Ophthalmic SuturingHNM1Specification developeraccessdata.fda.gov
Neurological TrayOJG1Complaint file establishment, Specification developeraccessdata.fda.gov
Nipper, MalleusJYR1Complaint file establishment, Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
Orthopedic TrayOJH1Complaint file establishment, Specification developeraccessdata.fda.gov
OsteotomeHWM1Complaint file establishmentaccessdata.fda.gov
Osteotome, ManualGFI1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Packer, UterineHDM1Complaint file establishment, Specification developeraccessdata.fda.gov
Perforator, AntrumKAT1Manufactureraccessdata.fda.gov
Pick, Microsurgical EarJYT1Manufactureraccessdata.fda.gov
Pliers, SurgicalHTC1Complaint file establishmentaccessdata.fda.gov
Pneumoperitoneum NeedleFHO2Complaint file establishmentaccessdata.fda.gov
ProbeHXB1Manufacturer, Specification developeraccessdata.fda.gov
Probe And Director, Gastro-UrologyFGM1Manufactureraccessdata.fda.gov
Probe, EntKAK1Manufactureraccessdata.fda.gov
Probe, LachrymalHNL1Complaint file establishment, Specification developeraccessdata.fda.gov
Probe, TrabeculotomyHNK1Complaint file establishmentaccessdata.fda.gov
Punch, AntrumKAW1Repackager or relabeleraccessdata.fda.gov
Punch, Corneo-ScleralHNJ1Complaint file establishmentaccessdata.fda.gov
Punch, EntKTF1Repackager or relabeleraccessdata.fda.gov
RaspHTR1Complaint file establishment, Specification developeraccessdata.fda.gov
Rasp, EarJYY1Manufactureraccessdata.fda.gov
Rasp, NasalKBA1Manufactureraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Manufactureraccessdata.fda.gov
Remover, Intrauterine Device, Contraceptive, Hook-TypeHHF1Complaint file establishmentaccessdata.fda.gov
Retainer, SurgicalGCZ1Complaint file establishment, Specification developeraccessdata.fda.gov
RetractorGAD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Retractor, All TypesEIG1Complaint file establishmentaccessdata.fda.gov
Retractor, EntKAL1Manufactureraccessdata.fda.gov
Retractor, FiberopticFDG1Manufactureraccessdata.fda.gov
Retractor, Non-Self-RetainingFGN1Manufactureraccessdata.fda.gov
Retractor, OphthalmicHNI1Manufactureraccessdata.fda.gov
Retractor, Self-RetainingFFO1Manufacturer, Specification developeraccessdata.fda.gov
Retractor, Self-Retaining, For NeurosurgeryGZT2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Retractor, VaginalHDL1Manufacturer, Specification developeraccessdata.fda.gov
Ring CutterFNS1Complaint file establishmentaccessdata.fda.gov
Ring, Ophthalmic (Flieringa)HNH1Specification developeraccessdata.fda.gov
Rod, Measuring EarJYZ1Manufactureraccessdata.fda.gov
RongeurHTX1Complaint file establishment, Specification developeraccessdata.fda.gov
Rongeur, ManualHAE2Complaint file establishment, Specification developeraccessdata.fda.gov
Rongeur, NasalKBB1Complaint file establishmentaccessdata.fda.gov
Saw, Manual And AccessoriesGDR1Complaint file establishmentaccessdata.fda.gov
Saw, NasalKBC1Complaint file establishmentaccessdata.fda.gov
Scalpel, One-PieceGDX1Manufactureraccessdata.fda.gov
Scissors, EarJZB1Specification developeraccessdata.fda.gov
Scissors, EpisiotomyHDK1Complaint file establishmentaccessdata.fda.gov
Scissors, General, SurgicalLRW1Manufactureraccessdata.fda.gov
Scissors, NasalKBD1Specification developeraccessdata.fda.gov
Scissors, OphthalmicHNF1Repackager or relabeleraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Complaint file establishmentaccessdata.fda.gov
Scissors, UmbilicalHDJ1Complaint file establishment, Specification developeraccessdata.fda.gov
ScoopFHL1Manufactureraccessdata.fda.gov
ScrewdriverHXX1Complaint file establishmentaccessdata.fda.gov
Snare, EarJZD1Complaint file establishmentaccessdata.fda.gov
Snare, EnucleatingHNE1Complaint file establishmentaccessdata.fda.gov
Snare, TonsilKBZ1Repackager or relabeleraccessdata.fda.gov
Sound, Urethral, Metal Or PlasticFBX1Manufacturer, Specification developeraccessdata.fda.gov
Sound, UterineHHM1Manufactureraccessdata.fda.gov
Spatula, OphthalmicHND1Manufactureraccessdata.fda.gov
Spatula, Surgical, General & Plastic SurgeryGAF1Complaint file establishmentaccessdata.fda.gov
Specula, OphthalmicHNC1Specification developeraccessdata.fda.gov
Speculum, EntEPY1Specification developeraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Specification developeraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Specification developeraccessdata.fda.gov
Spoon, OphthalmicHNB1Specification developeraccessdata.fda.gov
Spud, OphthalmicHNA1Complaint file establishment, Specification developeraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Stripper, SurgicalHRT1Specification developeraccessdata.fda.gov
Stylet For Catheter, Gastro-UrologyEZB1Manufactureraccessdata.fda.gov
Stylet, Surgical, General & Plastic SurgeryGAH1Complaint file establishmentaccessdata.fda.gov
Sucker, Cardiotomy Return, Cardiopulmonary BypassDTS2Complaint file establishment, Specification developeraccessdata.fda.gov
TampHXG1Manufactureraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Repackager or relabeleraccessdata.fda.gov
Tenaculum, UterineHDC2Specification developeraccessdata.fda.gov
Tray, SurgicalLRP1Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
TrephineHWK1Complaint file establishmentaccessdata.fda.gov
Trocar, EntKTE1Complaint file establishmentaccessdata.fda.gov
Tube, Ear SuctionJZF1Manufactureraccessdata.fda.gov
Tube, Tonsil SuctionKCB1Complaint file establishmentaccessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, LaparoscopicNKC1Complaint file establishmentaccessdata.fda.gov
Unit, Electrosurgical And Coagulation, With AccessoriesBWA2Complaint file establishmentaccessdata.fda.gov
UrethrotomeEZO2Specification developeraccessdata.fda.gov
Wrap, SterilizationFRG2Complaint file establishment, Specification developeraccessdata.fda.gov
WrenchHXC1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 25, 2021K213386Titan Manufacturing Bipolar ForcepsGEISubstantially EquivalentTitan Manufacturing, Inc.accessdata.fda.gov
March 4, 2021K210324V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186DXCSubstantially EquivalentCarefusion 2200, Inc.accessdata.fda.gov
March 21, 2016K153554Genesis Low Temperature Reusable Rigid Container SystemKCTSubstantially EquivalentCarefusion 2200, Inc.accessdata.fda.gov
February 1, 2016K151036Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic InstrumentsGCJSubstantially EquivalentCarefusion 2200, Inc.accessdata.fda.gov
December 23, 2015K151567ENDOPLUS hand-held laparoscopic instrumentsHFISubstantially EquivalentEndoplusaccessdata.fda.gov
January 8, 2015K142529Genesis Reusable Rigid Container SystemKCTSubstantially EquivalentCarefusion 2200, Inc.accessdata.fda.gov
August 27, 2014K140850GENESIS REUSABLE RIGID CONTAINER SYSTEMKCTSubstantially EquivalentCarefusion 2200, Inc.accessdata.fda.gov
April 21, 2014K140761KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULAHESSubstantially EquivalentCarefusion 2200, Inc.accessdata.fda.gov
January 17, 2013K123110PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301GCJSubstantially EquivalentSurgical Innovations Plcaccessdata.fda.gov
September 7, 2012K113407SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORSGEISubstantially EquivalentCarefusion 2200, Inc.accessdata.fda.gov
April 27, 2012K112535GENESIS REUSABLE RIGID CONTAINER SYSTEMKCTSubstantially EquivalentCarefusion 2200, Inc.accessdata.fda.gov
March 9, 2012K112659SURGICAL RETRACTORSGCJSubstantially EquivalentSurgical Innovations Plcaccessdata.fda.gov
May 6, 2011K110257DIAMOND-FLEX(R) GRASPERSGCJSubstantially EquivalentCarefusion 2200, Inc.accessdata.fda.gov
April 15, 2011K110152SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORSJOJSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
September 7, 2010K100442FASTCLAMP ENDOSCOPIC CLAMPING SYSTEMGCJSubstantially EquivalentSurgical Innovations Group Plcaccessdata.fda.gov
August 31, 2010K100518INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054DWPSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
January 22, 2010K092684LAPAROSCOPIC RETRACTORSGCJSubstantially EquivalentCardinal Health, Inc.accessdata.fda.gov
December 3, 2009K092840INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICALHCZSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
October 26, 2009K092544INSTRUMED VASCULAR CLAMPSDXCSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
March 18, 2009K090272SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)GZTSubstantially EquivalentCardinal Health, Inc.accessdata.fda.gov
August 8, 2008K081651INSTRUMED RONGEURHAESubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
August 2, 2007K071771INSTRUMED RETRACTORSGZTSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
July 19, 2006K060233TROKAMED GMBH ENDOSCOPES AND ACCESSORIESGCJSubstantially EquivalentTrokamed GmbHaccessdata.fda.gov
October 22, 2004K040223POLYVAC INSTRUMENT DELIVERY SYSTEMKCTSubstantially EquivalentSymmetry Medical USA, Inc.accessdata.fda.gov
April 16, 2004K040855INSTRUMED LAPAROSCOPE AND ACCESSORIESGEISubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
April 4, 2003K030890SWITCHBLADEGEISubstantially EquivalentSnowden Pencer, Inc.accessdata.fda.gov
August 20, 2002K012931GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEMFRGSubstantially EquivalentAllegiance Healthcare Corp.accessdata.fda.gov
August 29, 2000K002276PSI SKULL CLAMPHBLSubstantially EquivalentV. Mueller Neuro/Spineaccessdata.fda.gov
August 4, 2000K983299ALLEGIANCE GENESIS CONTAINER SYSTEMFRGSubstantially EquivalentAllegiance Healthcare Corp.accessdata.fda.gov
June 25, 1999K991928MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORSGCJSubstantially EquivalentAllegiance Healthcare Corp.accessdata.fda.gov
May 18, 1999K991589FLEXIBLE VASCULAR CLAMP, VERSION 2DXCSubstantially EquivalentAllegiance Healthcare Corp.accessdata.fda.gov
August 11, 1998K982465DEROYAL INDUSTRIES, INC. DEFOGGEROCTSubstantially EquivalentDeroyal Industries, Inc.accessdata.fda.gov
July 9, 1998K981956DEGANIA SILICONE IDENTI LOOPSDXCSubstantially EquivalentDegania Silicone , Ltd.accessdata.fda.gov
June 24, 1998K974595CUSHING BAYONET, INSULATED BIPOLAR FORCEPHTDSubstantially EquivalentTitan Mfg., Inc.accessdata.fda.gov
June 24, 1998K974594SEMKIN BIPOLAR FORCEPHTDSubstantially EquivalentTitan Mfg., Inc.accessdata.fda.gov
June 24, 1998K974593SEMKIN INSULATED BIPOLAR FORCEPHTDSubstantially EquivalentTitan Mfg., Inc.accessdata.fda.gov
June 12, 1998K974769COSGROVE CLAMPDXCSubstantially EquivalentAllegiance Healthcare Corp.accessdata.fda.gov
August 14, 1997K971540AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORDGEISubstantially EquivalentAmerican Biosurgical, Inc.accessdata.fda.gov
January 23, 1997K964402VERSATRAC (TM) LUMBAR RETRACTOR SYSTEMGZTSubstantially EquivalentV. Mueller Neuro/Spineaccessdata.fda.gov
August 18, 1995K951413FOGARTY-HYDRAGRIP SURGICAL CLAMPSDXCSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
November 22, 1994K944025SURGICAL INSTRUMENT TRAYFSMSubstantially EquivalentRiley Medical, Inc.accessdata.fda.gov
August 24, 1994K925079LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER)HETSubstantially EquivalentEndo Technic Corp.accessdata.fda.gov
May 19, 1994K930666REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERYGEISubstantially EquivalentSnowden-Penceraccessdata.fda.gov
May 16, 1994K930667REUSABLE LAPAROSCOPIC INSTRUMENTSGCJSubstantially EquivalentSnowden-Penceraccessdata.fda.gov
February 28, 1994K925114LAPAROSCOPIC INSTRUMENTSHFISubstantially EquivalentEndo Technic Corp.accessdata.fda.gov
July 1, 1993K931340GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTORGCSSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
November 27, 1991K914426ENTREE NEEDLEFHOSubstantially EquivalentCore Dynamics, Inc.accessdata.fda.gov
September 25, 1991K913500CHERRY SPONGEGCJSubstantially EquivalentO.R. Concepts, Inc.accessdata.fda.gov
December 10, 1990K904173INSULATED ELECTRODES AND LAPAROSCOPIC PROBICSHETSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
April 23, 1990K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFSTSubstantially EquivalentCuda Products Co.accessdata.fda.gov
October 19, 1989K895395V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTORGZTSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
December 12, 1984K844652C.A.S.E. CONTAINERFSMSubstantially EquivalentGeneral Medical Co.accessdata.fda.gov
July 28, 1981K811820BIPOLAR COAGULATING FORCEPSGEISubstantially EquivalentNew England Surgical Instrument Corp.accessdata.fda.gov

Compare with other makers

Updated October 25, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.