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Data / Medical devices / Germany / Jarit GmbH

Jarit GmbH: FDA-registered device maker in Rietheim-Weilheim Baden-Wurttemberg, Germany, 28 510(k) clearances

Jarit GmbH is registered with the FDA (registration 3005809810) in Rietheim-Weilheim Baden-Wurttemberg, Germany. It lists 258 device types. The FDA files 28 510(k) clearances under its listings, the newest dated April 16, 2015. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3005809810
Address
Langes Gewand 9, Rietheim-Weilheim Baden-Wurttemberg, Germany, 78604
Owner or operator
Integra LifeSciences Corporation (9004007)
Roles
Repackager or relabeler
First device listed
February 24, 1981
Registered through
2026
Brand names listed
225520; 225525; P4480; P4835; P710; PM-4480; PM-4835; PM-710, 33-31;33-31A;33-31AA;33-31AA-P/25;33-31A-P/25;33-31B;33-31-P/25;33-32;33-32-P/25;33-33;33-33-SH;33-34;33-34-P/25, 33-34-SH;33-35;33-35-SH;33-36;33-36-SH;33-37;33-38, 33-52;33-53;33-54;33-55;33-57, 5-700;5-702;5801;5803;5804, 5-800, Arkis Galea Elevator, Arkis Subcutaneous Guideware and more

Devices it lists

DeviceProduct codeClassRoleSource
Adaptor, Bulbs, Miscellaneous, For EndoscopeFFY1Repackager or relabeleraccessdata.fda.gov
AdenotomeKBH1Repackager or relabeleraccessdata.fda.gov
AmniotomeHGE1Repackager or relabeleraccessdata.fda.gov
Applicator, EntKCJ1Repackager or relabeleraccessdata.fda.gov
Applier, Surgical, ClipGDO1Repackager or relabeleraccessdata.fda.gov
AwlHWJ1Repackager or relabeleraccessdata.fda.gov
Basin, EmesisFNY1Repackager or relabeleraccessdata.fda.gov
Bistoury, TrachealKCC1Repackager or relabeleraccessdata.fda.gov
Bit, DrillHTW1Repackager or relabeleraccessdata.fda.gov
Block, Cutting, Ent, Non-SterileNNR1Repackager or relabeleraccessdata.fda.gov
Bone MillLYS1Repackager or relabeleraccessdata.fda.gov
Bur, DentalEJL1Repackager or relabeleraccessdata.fda.gov
Bur, Ear, Nose And ThroatEQJ1Repackager or relabeleraccessdata.fda.gov
Burnisher, OperativeEKJ1Repackager or relabeleraccessdata.fda.gov
Burr, OrthopedicHTT1Repackager or relabeleraccessdata.fda.gov
CaliperKTZ1Repackager or relabeleraccessdata.fda.gov
Caliper, OphthalmicHOE1Repackager or relabeleraccessdata.fda.gov
Cannula, CatheterDQR2Repackager or relabeleraccessdata.fda.gov
Cannula, InjectionFGY1Repackager or relabeleraccessdata.fda.gov
Cannula, OphthalmicHMX1Repackager or relabeleraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Repackager or relabeleraccessdata.fda.gov
Carrier, LigatureGEJ1Repackager or relabeleraccessdata.fda.gov
Carver, Wax, DentalEIK1Repackager or relabeleraccessdata.fda.gov
Chisel, Bone, SurgicalEML1Repackager or relabeleraccessdata.fda.gov
Chisel, MastoidJYD1Repackager or relabeleraccessdata.fda.gov
Chisel, Middle-EarJYE1Repackager or relabeleraccessdata.fda.gov
Chisel, NasalKAN1Repackager or relabeleraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Repackager or relabeleraccessdata.fda.gov
ClampHXD1Repackager or relabeleraccessdata.fda.gov
Clamp, Non-ElectricalFFN1Repackager or relabeleraccessdata.fda.gov
Clamp, Ossicle HoldingJYF1Repackager or relabeleraccessdata.fda.gov
Clamp, PenileFHA1Repackager or relabeleraccessdata.fda.gov
Clamp, Rubber DamEEF1Repackager or relabeleraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Repackager or relabeleraccessdata.fda.gov
Clamp, VascularDXC2Repackager or relabeleraccessdata.fda.gov
Clip, ScalpHBO2Repackager or relabeleraccessdata.fda.gov
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)KNF2Repackager or relabeleraccessdata.fda.gov
Condenser, Amalgam And Foil, OperativeEKG1Repackager or relabeleraccessdata.fda.gov
Contractor, SurgicalFZR1Repackager or relabeleraccessdata.fda.gov
Curette, AdenoidKBJ1Repackager or relabeleraccessdata.fda.gov
Curette, EarJYG1Repackager or relabeleraccessdata.fda.gov
Curette, NasalKAP1Repackager or relabeleraccessdata.fda.gov
Curette, OphthalmicHNZ1Repackager or relabeleraccessdata.fda.gov
Curette, PeriodonticEMS1Repackager or relabeleraccessdata.fda.gov
Curette, Surgical, DentalEMK1Repackager or relabeleraccessdata.fda.gov
Curette, Surgical, General UseFZS1Repackager or relabeleraccessdata.fda.gov
Curette, UterineHCY1Repackager or relabeleraccessdata.fda.gov
Cutter, SurgicalFZT1Repackager or relabeleraccessdata.fda.gov
Cutter, WireHXZ1Repackager or relabeleraccessdata.fda.gov
CystotomeHNY1Repackager or relabeleraccessdata.fda.gov
Depressor, Metal Tongue, SurgicalKBL1Repackager or relabeleraccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Repackager or relabeleraccessdata.fda.gov
Device, Locking, For Intestinal ClampFFR1Repackager or relabeleraccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Repackager or relabeleraccessdata.fda.gov
Dilator, LachrymalHNW1Repackager or relabeleraccessdata.fda.gov
Dilator, TrachealKCG1Repackager or relabeleraccessdata.fda.gov
Dilator, Vessel, SurgicalDWP2Repackager or relabeleraccessdata.fda.gov
Discriminator, Two-PointGWI1Repackager or relabeleraccessdata.fda.gov
Disk, AbrasiveEHJ1Repackager or relabeleraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Repackager or relabeleraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Manual)HBG2Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
Elevator, EntKAD1Repackager or relabeleraccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Repackager or relabeleraccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Repackager or relabeleraccessdata.fda.gov
Endoscope, NeurologicalGWG2Repackager or relabeleraccessdata.fda.gov
Excavator, Dental, OperativeEKC1Repackager or relabeleraccessdata.fda.gov
Excavator, EarJYH1Repackager or relabeleraccessdata.fda.gov
Expander, Surgical, Skin GraftFZW1Repackager or relabeleraccessdata.fda.gov
Explorer, OperativeEKB1Repackager or relabeleraccessdata.fda.gov
FileHTP1Repackager or relabeleraccessdata.fda.gov
File, Surgical, General & Plastic SurgeryGEO1Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Forceps, Articulation PaperEFK1Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Repackager or relabeleraccessdata.fda.gov
Forceps, Dressing, DentalEFL1Repackager or relabeleraccessdata.fda.gov
Forceps, EntKAE1Repackager or relabeleraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Repackager or relabeleraccessdata.fda.gov
Forceps, ObstetricalHDA2Repackager or relabeleraccessdata.fda.gov
Forceps, OphthalmicHNR1Repackager or relabeleraccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Repackager or relabeleraccessdata.fda.gov
Forceps, Rubber Dam ClampEJG1Repackager or relabeleraccessdata.fda.gov
Forceps, Surgical, GynecologicalHCZ2Repackager or relabeleraccessdata.fda.gov
Forceps, Tooth Extractor, SurgicalEMG1Repackager or relabeleraccessdata.fda.gov
Forceps, Tube IntroductionBWB1Repackager or relabeleraccessdata.fda.gov
Forceps, Wire HoldingHYA1Repackager or relabeleraccessdata.fda.gov
Fork, TuningGWX1Repackager or relabeleraccessdata.fda.gov
Frame, Rubber DamEJE1Repackager or relabeleraccessdata.fda.gov
Gag, MouthKBN1Repackager or relabeleraccessdata.fda.gov
Gauge, DepthHTJ1Repackager or relabeleraccessdata.fda.gov
Gauge, Depth, Instrument, DentalEIL1Repackager or relabeleraccessdata.fda.gov
Gauge, MeasuringJYJ1Repackager or relabeleraccessdata.fda.gov
Goniometer, NonpoweredKQW1Repackager or relabeleraccessdata.fda.gov
Gouge, Nasal, EntKAQ1Repackager or relabeleraccessdata.fda.gov
Gouge, Surgical, General & Plastic SurgeryGDH1Repackager or relabeleraccessdata.fda.gov
Graft, Vascular, Stainless Steel TunnelerMZY2Repackager or relabeleraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Repackager or relabeleraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Repackager or relabeleraccessdata.fda.gov
Hammer, SurgicalFZY1Repackager or relabeleraccessdata.fda.gov
Handle, Instrument, DentalEJB1Repackager or relabeleraccessdata.fda.gov
Handle, ScalpelGDZ1Repackager or relabeleraccessdata.fda.gov
Handpiece (Brace), DrillHBD1Repackager or relabeleraccessdata.fda.gov
HemostatHRQ1Repackager or relabeleraccessdata.fda.gov
Hemostat, SurgicalEMD1Repackager or relabeleraccessdata.fda.gov
Holder, Ear SpeculumJYK1Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Repackager or relabeleraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Repackager or relabeleraccessdata.fda.gov
Hook, Microsurgical EarJYL1Repackager or relabeleraccessdata.fda.gov
Hook, OphthalmicHNQ1Repackager or relabeleraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Repackager or relabeleraccessdata.fda.gov
Hook, TrachealKCH1Repackager or relabeleraccessdata.fda.gov
ImpactorHWA1Repackager or relabeleraccessdata.fda.gov
Inserter, Myringotomy TubeJYM1Repackager or relabeleraccessdata.fda.gov
Instrument, Cast Application/Removal, ManualLGG1Repackager or relabeleraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Repackager or relabeleraccessdata.fda.gov
Instrument, Diamond, DentalDZP1Repackager or relabeleraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Repackager or relabeleraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Repackager or relabeleraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Repackager or relabeleraccessdata.fda.gov
Knife, AmputationGDN1Repackager or relabeleraccessdata.fda.gov
Knife, EarJYO1Repackager or relabeleraccessdata.fda.gov
Knife, EntKTG1Repackager or relabeleraccessdata.fda.gov
Knife, LaryngealJZY1Repackager or relabeleraccessdata.fda.gov
Knife, MyringotomyJYP1Repackager or relabeleraccessdata.fda.gov
Knife, NasalKAS1Repackager or relabeleraccessdata.fda.gov
Knife, OphthalmicHNN1Repackager or relabeleraccessdata.fda.gov
Knife, OrthopedicHTS1Repackager or relabeleraccessdata.fda.gov
Knife, SurgicalEMF1Repackager or relabeleraccessdata.fda.gov
Knife, TonsilKBQ1Repackager or relabeleraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Repackager or relabeleraccessdata.fda.gov
Laparoscopic Accessories, GynecologicNWV1Repackager or relabeleraccessdata.fda.gov
Ligator, HemorrhoidalFHN2Repackager or relabeleraccessdata.fda.gov
Light Source, Fiberoptic, RoutineFCW2Repackager or relabeleraccessdata.fda.gov
Loop, WireJYQ1Repackager or relabeleraccessdata.fda.gov
Magnet, PermanentHPN1Repackager or relabeleraccessdata.fda.gov
MalletHXL1Repackager or relabeleraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Repackager or relabeleraccessdata.fda.gov
Marker, PeriodonticEMP1Repackager or relabeleraccessdata.fda.gov
Marker, SkinFZZ1Repackager or relabeleraccessdata.fda.gov
Mirror, EntKAI1Repackager or relabeleraccessdata.fda.gov
Mirror, General & Plastic SurgeryFTX1Repackager or relabeleraccessdata.fda.gov
Mirror, MouthEAX1Repackager or relabeleraccessdata.fda.gov
Mobilizer, EntKAJ1Repackager or relabeleraccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Repackager or relabeleraccessdata.fda.gov
Needle, CatheterGCB1Repackager or relabeleraccessdata.fda.gov
Needle, Suturing, DisposableGAB1Repackager or relabeleraccessdata.fda.gov
Needle, Suturing, ReusableGDL1Repackager or relabeleraccessdata.fda.gov
Needle, Tonsil SuturingKBR1Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Repackager or relabeleraccessdata.fda.gov
OsteotomeHWM1Repackager or relabeleraccessdata.fda.gov
Osteotome, ManualGFI1Repackager or relabeleraccessdata.fda.gov
Packer, UterineHDM1Repackager or relabeleraccessdata.fda.gov
PasserHWQ1Repackager or relabeleraccessdata.fda.gov
Passer, Wire, OrthopedicHXI1Repackager or relabeleraccessdata.fda.gov
Pelvimeter, ExternalHER1Repackager or relabeleraccessdata.fda.gov
PercussorGWZ1Repackager or relabeleraccessdata.fda.gov
Pick, Microsurgical EarJYT1Repackager or relabeleraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Repackager or relabeleraccessdata.fda.gov
Pin, Fixation, ThreadedJDW2Repackager or relabeleraccessdata.fda.gov
PinwheelGWY1Repackager or relabeleraccessdata.fda.gov
Plier, OrthodonticJEX1Repackager or relabeleraccessdata.fda.gov
Pliers, OperativeEJY1Repackager or relabeleraccessdata.fda.gov
Pliers, SurgicalHTC1Repackager or relabeleraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Repackager or relabeleraccessdata.fda.gov
Press, VeinJYW1Repackager or relabeleraccessdata.fda.gov
ProbeHXB1Repackager or relabeleraccessdata.fda.gov
Probe And Director, Gastro-UrologyFGM1Repackager or relabeleraccessdata.fda.gov
Probe, EntKAK1Repackager or relabeleraccessdata.fda.gov
Probe, LachrymalHNL1Repackager or relabeleraccessdata.fda.gov
Probe, PeriodonticEIX1Repackager or relabeleraccessdata.fda.gov
Probe, Rectal, Non-PoweredEXX1Repackager or relabeleraccessdata.fda.gov
Punch, AdenoidKBS1Repackager or relabeleraccessdata.fda.gov
Punch, AntrumKAW1Repackager or relabeleraccessdata.fda.gov
Punch, EntKTF1Repackager or relabeleraccessdata.fda.gov
Punch, NasalKAY1Repackager or relabeleraccessdata.fda.gov
Punch, SurgicalLRY1Repackager or relabeleraccessdata.fda.gov
Punch, TonsilKBT1Repackager or relabeleraccessdata.fda.gov
Pusher, Band, OrthodonticECS1Repackager or relabeleraccessdata.fda.gov
RaspHTR1Repackager or relabeleraccessdata.fda.gov
Rasp, EarJYY1Repackager or relabeleraccessdata.fda.gov
Rasp, Frontal-SinusKAZ1Repackager or relabeleraccessdata.fda.gov
Rasp, NasalKBA1Repackager or relabeleraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Repackager or relabeleraccessdata.fda.gov
Remover, CrownEIS1Repackager or relabeleraccessdata.fda.gov
Remover, Intrauterine Device, Contraceptive, Hook-TypeHHF1Repackager or relabeleraccessdata.fda.gov
Retainer, MatrixJEP1Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Repackager or relabeleraccessdata.fda.gov
Retractor, All TypesEIG1Repackager or relabeleraccessdata.fda.gov
Retractor, EntKAL1Repackager or relabeleraccessdata.fda.gov
Retractor, Non-Self-RetainingFGN1Repackager or relabeleraccessdata.fda.gov
Retractor, OphthalmicHNI1Repackager or relabeleraccessdata.fda.gov
Retractor, Self-RetainingFFO1Repackager or relabeleraccessdata.fda.gov
Retractor, VaginalHDL1Repackager or relabeleraccessdata.fda.gov
Ring CutterFNS1Repackager or relabeleraccessdata.fda.gov
Ring, LaparotomyFHI1Repackager or relabeleraccessdata.fda.gov
Rod, Measuring EarJYZ1Repackager or relabeleraccessdata.fda.gov
RongeurHTX1Repackager or relabeleraccessdata.fda.gov
Rongeur, ManualHAE2Repackager or relabeleraccessdata.fda.gov
Rongeur, MastoidJZA1Repackager or relabeleraccessdata.fda.gov
Rongeur, NasalKBB1Repackager or relabeleraccessdata.fda.gov
Saw, Manual And AccessoriesGDR1Repackager or relabeleraccessdata.fda.gov
Saw, NasalKBC1Repackager or relabeleraccessdata.fda.gov
Scaler, PeriodonticEMN1Repackager or relabeleraccessdata.fda.gov
Scissors, Collar And CrownEIR1Repackager or relabeleraccessdata.fda.gov
Scissors, EarJZB1Repackager or relabeleraccessdata.fda.gov
Scissors, EpisiotomyHDK1Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Repackager or relabeleraccessdata.fda.gov
Scissors, NasalKBD1Repackager or relabeleraccessdata.fda.gov
Scissors, OphthalmicHNF1Repackager or relabeleraccessdata.fda.gov
Scissors, Surgical Tissue, DentalEGN1Repackager or relabeleraccessdata.fda.gov
Scissors, UmbilicalHDJ1Repackager or relabeleraccessdata.fda.gov
Scissors, Wire Cutting, Ent, Non-SterileNNU1Repackager or relabeleraccessdata.fda.gov
ScoopFHL1Repackager or relabeleraccessdata.fda.gov
Screw, TonsilKBX1Repackager or relabeleraccessdata.fda.gov
ScrewdriverHXX1Repackager or relabeleraccessdata.fda.gov
Skid, BoneHWO1Repackager or relabeleraccessdata.fda.gov
Snare, EarJZD1Repackager or relabeleraccessdata.fda.gov
Snare, NasalKBE1Repackager or relabeleraccessdata.fda.gov
Snare, TonsilKBZ1Repackager or relabeleraccessdata.fda.gov
Sound, Urethral, Metal Or PlasticFBX1Repackager or relabeleraccessdata.fda.gov
Sound, UterineHHM1Repackager or relabeleraccessdata.fda.gov
Spatula, OphthalmicHND1Repackager or relabeleraccessdata.fda.gov
Spatula, OrthopedicHXR1Repackager or relabeleraccessdata.fda.gov
Spatula, Surgical, General & Plastic SurgeryGAF1Repackager or relabeleraccessdata.fda.gov
Specula AccessoriesFXG1Repackager or relabeleraccessdata.fda.gov
Specula, OphthalmicHNC1Repackager or relabeleraccessdata.fda.gov
Speculum, EntEPY1Repackager or relabeleraccessdata.fda.gov
Speculum, RectalFFQ1Repackager or relabeleraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Repackager or relabeleraccessdata.fda.gov
Spoon, OphthalmicHNB1Repackager or relabeleraccessdata.fda.gov
Spud, OphthalmicHNA1Repackager or relabeleraccessdata.fda.gov
Stripper, SurgicalHRT1Repackager or relabeleraccessdata.fda.gov
Stripper, Vein, ReusableGAI1Repackager or relabeleraccessdata.fda.gov
Stylet For Catheter, Gastro-UrologyEZB1Repackager or relabeleraccessdata.fda.gov
Stylet, Surgical, General & Plastic SurgeryGAH1Repackager or relabeleraccessdata.fda.gov
Support, Patient PositionCCX1Repackager or relabeleraccessdata.fda.gov
Syringe, CartridgeEJI2Repackager or relabeleraccessdata.fda.gov
Syringe, EntKCP1Repackager or relabeleraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Repackager or relabeleraccessdata.fda.gov
Table And Attachments, Operating-RoomBWN1Repackager or relabeleraccessdata.fda.gov
TampHXG1Repackager or relabeleraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Repackager or relabeleraccessdata.fda.gov
TemplateHWT1Repackager or relabeleraccessdata.fda.gov
Tenaculum, UterineHDC2Repackager or relabeleraccessdata.fda.gov
Tonometer, ManualHKY2Repackager or relabeleraccessdata.fda.gov
Tourniquet, Gastro-UrologyEYR1Repackager or relabeleraccessdata.fda.gov
Tray, SurgicalLRP1Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Repackager or relabeleraccessdata.fda.gov
TrephineHWK1Repackager or relabeleraccessdata.fda.gov
Trephine, Manual, OphthalmicHRH1Repackager or relabeleraccessdata.fda.gov
Trocar, EntKTE1Repackager or relabeleraccessdata.fda.gov
Tube, Ear SuctionJZF1Repackager or relabeleraccessdata.fda.gov
Twister, WireHXS1Repackager 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
April 16, 2015K150428Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison RongeursHAESubstantially EquivalentIntegra Lifesciences Corp.accessdata.fda.gov
February 20, 2015K150024Bissinger Monopolar CablesGEISubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
October 30, 2014K142414Miltex N-Tralig Intraligamentary SyringeEJISubstantially EquivalentIntegra LifeSciences Corporationaccessdata.fda.gov
April 11, 2014K134047JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPSHCZSubstantially EquivalentIntegra LifeSciences Corporationaccessdata.fda.gov
October 28, 2013K131446INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLESDQRSubstantially EquivalentIntegra LifeSciences Corporationaccessdata.fda.gov
May 14, 2013K123077VASCULAR CLAMPSDXCSubstantially EquivalentHebumedical GmbHaccessdata.fda.gov
September 11, 2012K120012INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTSGCJSubstantially EquivalentIntegra LifeSciences Corporationaccessdata.fda.gov
December 20, 2011K102921ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIESGEISubstantially EquivalentBema-GmbH & Co. KGaccessdata.fda.gov
November 9, 2010K102048ATRAUMATIC VASCULAR CLAMPSDXCSubstantially EquivalentGeomed Medizin-Technik GmbH & Co. KGaccessdata.fda.gov
September 10, 2010K100736KIRSCHNER AND GUIDE WIRESHTYSubstantially EquivalentSmt Schilling Metalltechnik GmbHaccessdata.fda.gov
March 9, 2009K083796MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHTEJISubstantially EquivalentMiltex, Inc.accessdata.fda.gov
November 21, 2008K082349JARIT HULKA UTERINE TENACULUM FORCEPSHDCSubstantially EquivalentJ. Jamner Surgical Instruments, Inc.accessdata.fda.gov
July 19, 2006K060233TROKAMED GMBH ENDOSCOPES AND ACCESSORIESGCJSubstantially EquivalentTrokamed GmbHaccessdata.fda.gov
November 23, 2005K052745ASSISTO ARM SYSTEMSGWGSubstantially EquivalentGeomed Medizin-Technik GmbH & Co.accessdata.fda.gov
July 29, 2005K051429CLARIS NON-STICK BIPOLAR FORCEPSGEISubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
January 7, 2004K033660STORZ RANEY SCALP CLIP, MODEL 1-20-004-05HBOSubstantially EquivalentRudolf Storz GmbHaccessdata.fda.gov
July 12, 2003K030788KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORSDWPSubstantially EquivalentGeister Medizin Technik GmbHaccessdata.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
August 13, 1998K981751SINUSCOPE AND ACCESSORIESEOBSubstantially EquivalentHenke Sass Wolf of America, Inc.accessdata.fda.gov
August 6, 1998K981919BISSINGER CABLES, CAT. NO. 801000XXGEISubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
June 5, 1996K961113CNS INTERCHANGEABLE BIT CRANIAL DRILLHBGSubstantially EquivalentClinical Neuro Systems, LLCaccessdata.fda.gov
May 8, 1995K945541SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALEHKYSubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov
May 16, 1994K941541HSV LAPAROSCOPY SETGCJSubstantially EquivalentHenke Sass Wolf of America, Inc.accessdata.fda.gov
April 21, 1994K932456JARIT SURGICAL INSTRUMENTSKNFSubstantially EquivalentJ. Jamner Surgical Instruments, Inc.accessdata.fda.gov
February 23, 1994K933728JARIT SURGICAL INSTRUMENTS: CATALOG 615-330, 615-331, 615-334, 615-335, 615-338, 615-339GEISubstantially EquivalentJ. Jamner Surgical Instruments, Inc.accessdata.fda.gov
November 10, 1993K931928JARIT SURGICAL INSTRUMENTSGCJSubstantially EquivalentJ. Jamner Surgical Instruments, Inc.accessdata.fda.gov
October 5, 1993K931959JARIT SURGICAL INSTRUMENTSGEISubstantially EquivalentJ. Jamner Surgical Instruments, Inc.accessdata.fda.gov
September 20, 1990K902818MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENTHBGSubstantially EquivalentRuggles Corp.accessdata.fda.gov

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Updated April 16, 2015. 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.