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Data / Medical devices / United States / Novo Surgical, Inc.

Novo Surgical, Inc.: FDA-registered device maker in Westmont, IL, United States, 24 510(k) clearances

Novo Surgical, Inc. is registered with the FDA (registration 3008770252) in Westmont, IL, United States. It lists 298 device types. The FDA files 24 510(k) clearances under its listings, the newest dated October 25, 2021. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Novo Surgical, Inc.
FDA registration number
3008770252
Address
407 Plaza Drive, Westmont, IL, United States, 60559
Owner or operator
Novo Surgical Inc. (10034425)
Roles
Repackager or relabeler
First device listed
December 1, 2010
Registered through
2026
Brand names listed
Novo Dental Retractor Accessories, Novo Surgical Forceps, Dressing, Dental, Novo Surgical Forceps, Ent, Novo Surgical Forceps, Tooth Extractor, Surgical, Novo Surgical Holder, Needle, Gastroenterologic, Novo Surgical Retractor, All Types, Novo Surgical Sound, Uterine, Novo Surgical Speculum, Non-Illuminated and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Repackager or relabeleraccessdata.fda.gov
Accessories, Cleaning Brushes, For EndoscopeMNL1Repackager or relabeleraccessdata.fda.gov
Accessories, Retractor, DentalEIF1Repackager or relabeleraccessdata.fda.gov
AdenotomeKBH1Repackager or relabeleraccessdata.fda.gov
Applicator, EntKCJ1Repackager or relabeleraccessdata.fda.gov
Applier, Hemostatic ClipHBT1Repackager or relabeleraccessdata.fda.gov
Applier, Surgical, ClipGDO1Repackager or relabeleraccessdata.fda.gov
AwlHWJ1Repackager or relabeleraccessdata.fda.gov
Basin, EmesisFNY1Repackager or relabeleraccessdata.fda.gov
Bit, DrillHTW1Repackager or relabeleraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Repackager or relabeleraccessdata.fda.gov
Blade, ScalpelGES1Repackager or relabeleraccessdata.fda.gov
Block, Cutting, Ent, Non-SterileNNR1Repackager or relabeleraccessdata.fda.gov
Bougie, UrologicalFAX1Repackager or relabeleraccessdata.fda.gov
Brace, DrillHXY1Repackager or relabeleraccessdata.fda.gov
Brush, Scrub, Operating-RoomGEC1Repackager or relabeleraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Repackager or relabeleraccessdata.fda.gov
Burnisher, OperativeEKJ1Repackager or relabeleraccessdata.fda.gov
Burr, Corneal, Battery Powered, Rust Ring RemovalOHW1Repackager or relabeleraccessdata.fda.gov
Burr, Corneal, ManualHOF1Repackager or relabeleraccessdata.fda.gov
Burr, OrthopedicHTT1Repackager or relabeleraccessdata.fda.gov
CaliperKTZ1Repackager or relabeleraccessdata.fda.gov
Caliper, OphthalmicHOE1Repackager or relabeleraccessdata.fda.gov
Cannula And Trocar, Suprapubic, Non-DisposableFBM1Repackager or relabeleraccessdata.fda.gov
Cannula, EarJYC1Repackager or relabeleraccessdata.fda.gov
Cannula, Manipulator/Injector, UterineLKF2Repackager or relabeleraccessdata.fda.gov
Cannula, OphthalmicHMX1Repackager or relabeleraccessdata.fda.gov
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl AcetalMXY1Repackager or relabeleraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Repackager or relabeleraccessdata.fda.gov
Cannula, VentricularHCD1Repackager or relabeleraccessdata.fda.gov
Carrier, Amalgam, OperativeEKI1Repackager or relabeleraccessdata.fda.gov
Carrier, LigatureGEJ1Repackager or relabeleraccessdata.fda.gov
Carver, Dental Amalgam, OperativeEKH1Repackager or relabeleraccessdata.fda.gov
Carver, Wax, DentalEIK1Repackager or relabeleraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Repackager or relabeleraccessdata.fda.gov
Chisel (Osteotome)KDG1Repackager or relabeleraccessdata.fda.gov
Chisel, Bone, SurgicalEML1Repackager or relabeleraccessdata.fda.gov
Chisel, Middle-EarJYE1Repackager or relabeleraccessdata.fda.gov
Chisel, NasalKAN1Repackager or relabeleraccessdata.fda.gov
Chisel, Osteotome, SurgicalEMM1Repackager or relabeleraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Repackager or relabeleraccessdata.fda.gov
ClampHXD1Repackager or relabeleraccessdata.fda.gov
Clamp, Eyelid, OphthalmicHOD1Repackager 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, UterineHGC1Repackager or relabeleraccessdata.fda.gov
Clamp, VascularDXC2Repackager or relabeleraccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Repackager or relabeleraccessdata.fda.gov
Clip, AneurysmHCH2Repackager or relabeleraccessdata.fda.gov
Clip, HemostaticMCH2Repackager or relabeleraccessdata.fda.gov
Clip, ImplantableFZP2Repackager or relabeleraccessdata.fda.gov
Clip, Removable (Skin)FZQ1Repackager or relabeleraccessdata.fda.gov
Clip, ScalpHBO2Repackager or relabeleraccessdata.fda.gov
Component, Traction, Non-InvasiveKQZ1Repackager or relabeleraccessdata.fda.gov
CorkscrewHWI1Repackager or relabeleraccessdata.fda.gov
Crimper, Wire, Ent, Non-SterileNNN1Repackager or relabeleraccessdata.fda.gov
CuretteHTF1Repackager or relabeleraccessdata.fda.gov
Curette, AdenoidKBJ1Repackager or relabeleraccessdata.fda.gov
Curette, EarJYG1Repackager or relabeleraccessdata.fda.gov
Curette, EthmoidKAO1Repackager or relabeleraccessdata.fda.gov
Curette, NasalKAP1Repackager or relabeleraccessdata.fda.gov
Curette, OperativeEKE1Repackager 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
Dam, RubberEIE1Repackager or relabeleraccessdata.fda.gov
Depressor, Metal Tongue, SurgicalKBL1Repackager or relabeleraccessdata.fda.gov
Depressor, OrbitalHNX1Repackager or relabeleraccessdata.fda.gov
DermatomeGFD1Repackager or relabeleraccessdata.fda.gov
Device, Fixation, Tracheal TubeCBH1Repackager or relabeleraccessdata.fda.gov
Device, Irrigation, Ocular SurgeryKYG1Repackager or relabeleraccessdata.fda.gov
Dilator, CatheterGCC1Repackager or relabeleraccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Repackager or relabeleraccessdata.fda.gov
Dilator, Esophageal, EntKCF1Repackager or relabeleraccessdata.fda.gov
Dilator, LachrymalHNW1Repackager or relabeleraccessdata.fda.gov
Dilator, RectalFFP1Repackager or relabeleraccessdata.fda.gov
Dilator, TrachealKCG1Repackager or relabeleraccessdata.fda.gov
Dilator, Vessel, SurgicalDWP2Repackager or relabeleraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Repackager or relabeleraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
ElevatorHTE1Repackager 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
Excavator, Dental, OperativeEKC1Repackager or relabeleraccessdata.fda.gov
Excavator, EarJYH1Repackager or relabeleraccessdata.fda.gov
Explorer, OperativeEKB1Repackager or relabeleraccessdata.fda.gov
FacebowKCR1Repackager or relabeleraccessdata.fda.gov
FileHTP1Repackager or relabeleraccessdata.fda.gov
File, Bone, SurgicalEMI1Repackager or relabeleraccessdata.fda.gov
File, PeriodonticEMR1Repackager or relabeleraccessdata.fda.gov
File, Surgical, General & Plastic SurgeryGEO1Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Repackager or relabeleraccessdata.fda.gov
Forceps, DisconnectFJR1Repackager 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, 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
Gag, MouthKBN1Repackager or relabeleraccessdata.fda.gov
Gauge, DepthHTJ1Repackager or relabeleraccessdata.fda.gov
Gauge, Depth, Instrument, DentalEIL1Repackager or relabeleraccessdata.fda.gov
Gauge, Lens, OphthalmicHLN1Repackager 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
Guide, Surgical, InstrumentFZX1Repackager or relabeleraccessdata.fda.gov
Hammer, SurgicalFZY1Repackager or relabeleraccessdata.fda.gov
Hand, External Limb Component, MechanicalIRA1Repackager 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
Holder, Ear SpeculumJYK1Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Repackager or relabeleraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Repackager or relabeleraccessdata.fda.gov
Hook, BoneKIK1Repackager or relabeleraccessdata.fda.gov
Hook, Fibroid, GynecologicalHDE1Repackager or relabeleraccessdata.fda.gov
Hook, Gastro-UrologyFHB1Repackager 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
Instrument, Cast Application/Removal, ManualLGG1Repackager or relabeleraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Repackager or relabeleraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Repackager or relabeleraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Repackager or relabeleraccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Repackager or relabeleraccessdata.fda.gov
Instrument, Ligature Tucking, OrthodonticECP1Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, General Obstetric-GynecologicKOH1Repackager 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, Surgical, CardiovascularDWS1Repackager or relabeleraccessdata.fda.gov
Introducer, SphereHNP1Repackager or relabeleraccessdata.fda.gov
Irrigator, SinusKAR1Repackager 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
Laryngoscope, RigidCCW1Repackager or relabeleraccessdata.fda.gov
Ligator, HemorrhoidalFHN2Repackager or relabeleraccessdata.fda.gov
Loop, WireJYQ1Repackager or relabeleraccessdata.fda.gov
MalletHXL1Repackager or relabeleraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Repackager or relabeleraccessdata.fda.gov
Marker, OcularHMR1Repackager or relabeleraccessdata.fda.gov
Marker, ScleraHMQ1Repackager 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
Needle, Aspiration And Injection, ReusableGDM1Repackager or relabeleraccessdata.fda.gov
Needle, Biopsy, CardiovascularDWO1Repackager or relabeleraccessdata.fda.gov
Needle, Ophthalmic SuturingHNM1Repackager or relabeleraccessdata.fda.gov
Needle, Suturing, ReusableGDL1Repackager or relabeleraccessdata.fda.gov
Needle, Tonsil SuturingKBR1Repackager or relabeleraccessdata.fda.gov
Nipper, MalleusJYR1Repackager 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
Pick, MassagingJET1Repackager or relabeleraccessdata.fda.gov
Pick, Microsurgical EarJYT1Repackager 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
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
Probe, TrabeculotomyHNK1Repackager or relabeleraccessdata.fda.gov
Punch, AdenoidKBS1Repackager or relabeleraccessdata.fda.gov
Punch, AntrumKAW1Repackager or relabeleraccessdata.fda.gov
Punch, Biopsy, SurgicalEME1Repackager or relabeleraccessdata.fda.gov
Punch, Corneo-ScleralHNJ1Repackager or relabeleraccessdata.fda.gov
Punch, EntKTF1Repackager or relabeleraccessdata.fda.gov
Punch, SurgicalLRY1Repackager or relabeleraccessdata.fda.gov
RaspHTR1Repackager or relabeleraccessdata.fda.gov
Rasp, EarJYY1Repackager or relabeleraccessdata.fda.gov
Rasp, NasalKBA1Repackager or relabeleraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Repackager or relabeleraccessdata.fda.gov
ReamerHTO1Repackager or relabeleraccessdata.fda.gov
Remover, Intrauterine Device, Contraceptive, Hook-TypeHHF1Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Repackager or relabeleraccessdata.fda.gov
Retractor, All TypesEIG1Repackager or relabeleraccessdata.fda.gov
Retractor, EntKAL1Repackager or relabeleraccessdata.fda.gov
Retractor, FiberopticFDG1Repackager 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, Self-Retaining, For NeurosurgeryGZT2Repackager or relabeleraccessdata.fda.gov
Retractor, VaginalHDL1Repackager or relabeleraccessdata.fda.gov
Ring CutterFNS1Repackager or relabeleraccessdata.fda.gov
Ring, Ophthalmic (Flieringa)HNH1Repackager or relabeleraccessdata.fda.gov
Rod, Measuring EarJYZ1Repackager or relabeleraccessdata.fda.gov
RongeurHTX1Repackager or relabeleraccessdata.fda.gov
Rongeur, NasalKBB1Repackager or relabeleraccessdata.fda.gov
SawHSO1Repackager 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, Medical, DisposableJOK1Repackager or relabeleraccessdata.fda.gov
Scissors, NasalKBD1Repackager or relabeleraccessdata.fda.gov
Scissors, OphthalmicHNF1Repackager or relabeleraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Repackager 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
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Repackager or relabeleraccessdata.fda.gov
Skid, BoneHWO1Repackager or relabeleraccessdata.fda.gov
Snare, EarJZD1Repackager or relabeleraccessdata.fda.gov
Snare, EnucleatingHNE1Repackager or relabeleraccessdata.fda.gov
Snare, NasalKBE1Repackager or relabeleraccessdata.fda.gov
Snare, Non-ElectricalFGX1Repackager 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
Source, Carrier, Fiberoptic LightEQH1Repackager 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, Non-IlluminatedFXE1Repackager or relabeleraccessdata.fda.gov
Speculum, RectalFFQ1Repackager or relabeleraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Repackager or relabeleraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Repackager or relabeleraccessdata.fda.gov
Spoon, OphthalmicHNB1Repackager or relabeleraccessdata.fda.gov
Spud, OphthalmicHNA1Repackager or relabeleraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Repackager or relabeleraccessdata.fda.gov
Stimulator, Muscle, PoweredIPF2Repackager or relabeleraccessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle ConditioningNGX2Repackager or relabeleraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain ReliefGZJ2Repackager or relabeleraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-CounterNUH2Repackager or relabeleraccessdata.fda.gov
Stripper, SurgicalHRT1Repackager or relabeleraccessdata.fda.gov
Stripper, Vein, ReusableGAI1Repackager or relabeleraccessdata.fda.gov
Stylet, Surgical, General & Plastic SurgeryGAH1Repackager or relabeleraccessdata.fda.gov
Stylet, UreteralEYA1Repackager or relabeleraccessdata.fda.gov
Support, Patient PositionCCX1Repackager or relabeleraccessdata.fda.gov
Surgical Instruments, G-U, Manual (And Accessories)KOA1Repackager or relabeleraccessdata.fda.gov
Syringe, EntKCP1Repackager or relabeleraccessdata.fda.gov
Syringe, Irrigating (Dental)EIB1Repackager or relabeleraccessdata.fda.gov
TampHXG1Repackager or relabeleraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Repackager or relabeleraccessdata.fda.gov
Tonometer, ManualHKY2Repackager or relabeleraccessdata.fda.gov
Tourniquet, Gastro-UrologyEYR1Repackager or relabeleraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Repackager 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
TrocarDRC2Repackager or relabeleraccessdata.fda.gov
Trocar, EntKTE1Repackager or relabeleraccessdata.fda.gov
Tube, Ear SuctionJZF1Repackager or relabeleraccessdata.fda.gov
Tube, LaryngectomyKAC1Repackager or relabeleraccessdata.fda.gov
Tube, Tonsil SuctionKCB1Repackager or relabeleraccessdata.fda.gov
Twister, WireHXS1Repackager or relabeleraccessdata.fda.gov
UrethrotomeEZO2Repackager 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
October 25, 2021K213386Titan Manufacturing Bipolar ForcepsGEISubstantially EquivalentTitan Manufacturing, Inc.accessdata.fda.gov
September 3, 2019K183438Geomed Vascular DilatorsDWPSubstantially EquivalentGeomed Medizin-Technik GmbH & Co.accessdata.fda.gov
March 22, 2019K181173ELMED Laparoscopic Instruments and AccessoriesGCJSubstantially EquivalentElmed Incorporatedaccessdata.fda.gov
June 29, 2017K163524Vessel DilatorDWPSubstantially EquivalentFetzer Medical GmbH & Co. KGaccessdata.fda.gov
August 12, 2014K131407BAHADIR STERILIZATION TRAYSKCTSubstantially EquivalentBahadir USA Corp.accessdata.fda.gov
November 8, 2011K111930ACKERMANN EUROPCLIPFZPSubstantially EquivalentAckermann Instrumente GmbHaccessdata.fda.gov
November 9, 2010K102048ATRAUMATIC VASCULAR CLAMPSDXCSubstantially EquivalentGeomed Medizin-Technik GmbH & Co. KGaccessdata.fda.gov
August 31, 2010K100518INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054DWPSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
June 21, 2010K101080NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXXGEISubstantially EquivalentEgon Faulhaber Surgical Instruments Pinzettenaccessdata.fda.gov
October 26, 2009K092544INSTRUMED VASCULAR CLAMPSDXCSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
January 9, 2008K072834SIBEL SA VASCULAR CLAMPDXCSubstantially EquivalentSurgical Instruments Belgium SAaccessdata.fda.gov
August 2, 2007K071771INSTRUMED RETRACTORSGZTSubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
July 19, 2006K060233TROKAMED GMBH ENDOSCOPES AND ACCESSORIESGCJSubstantially EquivalentTrokamed GmbHaccessdata.fda.gov
July 29, 2005K051429CLARIS NON-STICK BIPOLAR FORCEPSGEISubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
April 16, 2004K040855INSTRUMED LAPAROSCOPE AND ACCESSORIESGEISubstantially EquivalentInstrumed International, Inc.accessdata.fda.gov
January 7, 2004K033660STORZ RANEY SCALP CLIP, MODEL 1-20-004-05HBOSubstantially EquivalentRudolf Storz GmbHaccessdata.fda.gov
August 1, 2001K010908MEDICON TITANIUM YASARGIL ANEURYSM CLIPSHCHSubstantially EquivalentMedicon EGaccessdata.fda.gov
May 30, 2001K003500REBSTOCK YASARGIL ANEURYSM CLIPHCHSubstantially EquivalentRebstock - Instrumente GmbHaccessdata.fda.gov
June 24, 1998K974595CUSHING BAYONET, INSULATED BIPOLAR FORCEPHTDSubstantially EquivalentTitan Mfg., Inc.accessdata.fda.gov
April 21, 1998K974382ACKERMANN SURGICAL INSTRUMENTSGCJSubstantially EquivalentAckermann Instrumente GmbHaccessdata.fda.gov
March 19, 1998K974793ELMED ESU 120 M/M DIGITALGEISubstantially EquivalentElmed, Inc.accessdata.fda.gov
May 6, 1997K960738STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H)KCTSubstantially EquivalentEngineered Custom Mfg., Inc.accessdata.fda.gov
March 7, 1997K962545DENTAL, MEDICAL INSTRUMENT CASES & CASSETTEKCTSubstantially EquivalentSterilization Cassette Systems, Inc.accessdata.fda.gov
May 8, 1995K945541SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALEHKYSubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov

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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.