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Data / Medical devices / Germany / STERIS Deutschland GmBh

STERIS Deutschland GmBh: FDA-registered device maker in Wurmlingen Baden-Wurttemberg, Germany, 19 510(k) clearances

STERIS Deutschland GmBh is registered with the FDA (registration 3006554912) in Wurmlingen Baden-Wurttemberg, Germany. It lists 162 device types. The FDA files 19 510(k) clearances under its listings, the newest dated May 4, 2017. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number
3006554912
Address
Kantstrasse 33/1, Wurmlingen Baden-Wurttemberg, Germany, D-78573
Owner or operator
STERIS (10091086)
Roles
Exporter to the US, Repackager or relabeler
First device listed
June 27, 2024
Registered through
2027
Brand names listed
Affinity Forceps (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), Snowden Pencer Forceps (WM-FE, RR), Snowden Pencer Hemostat (ST-CFE, WM-FE,RR), Snowden Pencer Retractor (ST-MF.RR, WM-FE,RR) and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, CatheterKGZ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
AdenotomeKBH1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Anoscope And AccessoriesFER2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Brace, DrillHXY1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
CaliperKTZ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Caliper, OphthalmicHOE1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Cannula And Trocar, Suprapubic, Non-DisposableFBM1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Carrier, LigatureGEJ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Chisel, NasalKAN1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Chisel, Osteotome, SurgicalEMM1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
ClampHXD1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Clamp, Non-ElectricalFFN1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Clamp, Ossicle HoldingJYF1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Clamp, PenileFHA1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Clamp, UterineHGC1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Clamp, VascularDXC2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
CuretteHTF1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Curette, AdenoidKBJ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Curette, EarJYG1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Curette, NasalKAP1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Curette, OphthalmicHNZ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Curette, Surgical, DentalEMK1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Curette, Surgical, General UseFZS1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Curette, UterineHCY1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Cutter, SurgicalFZT1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Cutter, WireHXZ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Depressor, Metal Tongue, SurgicalKBL1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Device, Locking, For Intestinal ClampFFR1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Dilator, LachrymalHNW1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Dilator, TrachealKCG1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Dilator, UrethralKOE2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Manual)HBG2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
ElevatorHTE1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Elevator, EntKAD1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Elevator, UterineHDP2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
File, Bone, SurgicalEMI1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Forceps, Dressing, DentalEFL1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Forceps, EntKAE1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Forceps, ObstetricalHDA2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Forceps, OphthalmicHNR1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Forceps, Surgical, GynecologicalHCZ2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Forceps, Tube IntroductionBWB1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Forceps, Wire HoldingHYA1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Gag, MouthKBN1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Gauge, MeasuringJYJ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Handle, ScalpelGDZ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
HemostatHRQ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Hook, BoneKIK1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Hook, Fibroid, GynecologicalHDE1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Hook, Gastro-UrologyFHB1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Hook, Microsurgical EarJYL1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Hook, OphthalmicHNQ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Hook, Tonsil SuturingKBP1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Instrument, Cast Application/Removal, ManualLGG1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, General Obstetric-GynecologicKOH1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Knife, EarJYO1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Knife, EntKTG1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Knife, LaryngealJZY1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Knife, NasalKAS1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Knife, OphthalmicHNN1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Knife, SurgicalEMF1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Knife, TonsilKBQ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Laparoscopic Accessories, GynecologicNWV1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Ligator, HemorrhoidalFHN2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Loop, WireJYQ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
MalletHXL1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Marker, SkinFZZ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Mirror, EntKAI1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Needle, Biopsy, CardiovascularDWO1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Needle, Ophthalmic SuturingHNM1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Nipper, MalleusJYR1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
OsteotomeHWM1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Packer, UterineHDM1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Pelvimeter, ExternalHER1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
PercussorGWZ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Perforator, AntrumKAT1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Pick, Microsurgical EarJYT1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
PinwheelGWY1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Pliers, SurgicalHTC1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Probe And Director, Gastro-UrologyFGM1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Probe, EntKAK1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Probe, Rectal, Non-PoweredEXX1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Punch, AdenoidKBS1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Punch, AntrumKAW1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Punch, EntKTF1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Punch, TonsilKBT1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
RaspHTR1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Rasp, NasalKBA1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Retractor, EntKAL1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Retractor, Non-Self-RetainingFGN1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Retractor, OphthalmicHNI1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Retractor, Self-RetainingFFO1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Retractor, Self-Retaining, For NeurosurgeryGZT2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Retractor, VaginalHDL1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Ring, Ophthalmic (Flieringa)HNH1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
RongeurHTX1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Rongeur, ManualHAE2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Rongeur, NasalKBB1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Saw, Manual And AccessoriesGDR1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Saw, NasalKBC1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Scissors, EarJZB1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Scissors, EpisiotomyHDK1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Scissors, NasalKBD1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Scissors, OphthalmicHNF1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Scissors, Wire Cutting, Ent, Non-SterileNNU1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Scissors, Wire Cutting, Ent, SterileJYA1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
ScoopFHL1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Searcher, MastoidJZC1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Snare, EarJZD1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Snare, NasalKBE1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Snare, TonsilKBZ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Sound, Urethral, Metal Or PlasticFBX1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Sound, UterineHHM1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Spatula, OphthalmicHND1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Specula, OphthalmicHNC1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Speculum, EntEPY1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Speculum, RectalFFQ1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Spoon, OphthalmicHNB1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Spud, OphthalmicHNA1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Stripper, SurgicalHRT1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Stripper, Vein, ReusableGAI1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Surgical Instruments, G-U, Manual (And Accessories)KOA1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Syringe, EntKCP1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Tape, OrthopedicHXT1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Tenaculum, UterineHDC2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
TrephineHWK1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
TrocarDRC2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Tube, Ear SuctionJZF1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
UrethrotomeEZO2Exporter to the US, Repackager or relabeleraccessdata.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
May 4, 2017K163615Snowden-Pencer MicroLap 3mm Laparoscopic InstrumentsGEISubstantially EquivalentCarefusion 2200, Inc.accessdata.fda.gov
May 14, 2013K123077VASCULAR CLAMPSDXCSubstantially EquivalentHebumedical GmbHaccessdata.fda.gov
December 20, 2011K102921ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIESGEISubstantially EquivalentBema-GmbH & Co. KGaccessdata.fda.gov
October 26, 2009K092544INSTRUMED VASCULAR CLAMPSDXCSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
July 19, 2006K060233TROKAMED GMBH ENDOSCOPES AND ACCESSORIESGCJSubstantially EquivalentTrokamed GmbHaccessdata.fda.gov
July 12, 2006K060232TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIESGEISubstantially EquivalentTrokamed GmbHaccessdata.fda.gov
July 29, 2005K051429CLARIS NON-STICK BIPOLAR FORCEPSGEISubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
October 27, 2004K042077BITECH BIPOLAR SCISSORSGEISubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
April 24, 2000K000297ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGERFHNSubstantially EquivalentErchinger Medizintecnikaccessdata.fda.gov
October 7, 1999K992983BAHO AUTOCLAVABLE CYSTOSCOPEFAJSubstantially EquivalentInnovative Endoscopy Components, LLCaccessdata.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
April 8, 1999K982365ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMATDXCSubstantially EquivalentGeister Medizin Technik GmbHaccessdata.fda.gov
February 18, 1999K982276BAHO AUTOCLAVABLE LAPAROSCOPEHETSubstantially EquivalentMicroptix Int'L, LLCaccessdata.fda.gov
August 6, 1998K981919BISSINGER CABLES, CAT. NO. 801000XXGEISubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
April 21, 1998K974382ACKERMANN SURGICAL INSTRUMENTSGCJSubstantially EquivalentAckermann Instrumente GmbHaccessdata.fda.gov
May 19, 1994K930666REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERYGEISubstantially EquivalentSnowden-Penceraccessdata.fda.gov
May 16, 1994K930667REUSABLE LAPAROSCOPIC INSTRUMENTSGCJSubstantially EquivalentSnowden-Penceraccessdata.fda.gov
July 28, 1981K811820BIPOLAR COAGULATING FORCEPSGEISubstantially EquivalentNew England Surgical Instrument Corp.accessdata.fda.gov

Compare with other makers

Updated May 4, 2017. 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.