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Data / Medical devices / United States / JEDMED Instrument Company

JEDMED Instrument Company: FDA-registered device maker in Saint Louis, MO, United States, 14 510(k) clearances

JEDMED Instrument Company is registered with the FDA (registration 1926681) in Saint Louis, MO, United States. It lists 166 device types. The FDA files 14 510(k) clearances under its listings, the newest dated June 21, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
1926681
Address
5416 Jedmed CT., Saint Louis, MO, United States, 63129
Owner or operator
JEDMED INSTRUMENT CO. (1926681)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
October 29, 1982
Registered through
2026
Brand names listed
"J-II" MOTORIZED BASE), A390033, ADNOID PUNCH, ASPIRATOR, BALL BURNISHER, CHISEL, CORNEOSCLERAL, Classic Cabinet and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Cleaning Brushes, For EndoscopeMNL1Repackager or relabeleraccessdata.fda.gov
Accessories, Retractor, DentalEIF1Repackager or relabeleraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Manufactureraccessdata.fda.gov
Applicator, EntKCJ1Repackager or relabeleraccessdata.fda.gov
Applicator, Ocular PressureLCC2Repackager or relabeleraccessdata.fda.gov
Basin, EmesisFNY1Repackager or relabeleraccessdata.fda.gov
Biomicroscope, Slit-Lamp, Ac-PoweredHJO2Repackager or relabeleraccessdata.fda.gov
Block, Cutting, Ent, Non-SterileNNR1Repackager or relabeleraccessdata.fda.gov
Blower, Powder, EntKCL1Repackager or relabeleraccessdata.fda.gov
Bottle, Collection And Trap, Breathing System (Uncalibrated)CBC2Repackager or relabeleraccessdata.fda.gov
Bur, Ear, Nose And ThroatEQJ1Repackager or relabeleraccessdata.fda.gov
Burnisher, OperativeEKJ1Repackager or relabeleraccessdata.fda.gov
Button, Nasal SeptalLFBURepackager or relabeleraccessdata.fda.gov
Caliper, OphthalmicHOE1Repackager or relabeleraccessdata.fda.gov
Camera, Ophthalmic, Ac-PoweredHKI2Repackager or relabeleraccessdata.fda.gov
Camera, Ophthalmic, General-UsePJZ2Repackager or relabeleraccessdata.fda.gov
Camera, Surgical And AccessoriesKQM1Repackager or relabeleraccessdata.fda.gov
Camera, Television, Microsurgical, Without AudioFWD1Repackager or relabeleraccessdata.fda.gov
Cannula, EarJYC1Repackager or relabeleraccessdata.fda.gov
Cannula, OphthalmicHMX1Repackager or relabeleraccessdata.fda.gov
Cannula, SinusKAM1Repackager or relabeleraccessdata.fda.gov
Chair And Table, MedicalKMN1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Chair, Examination And TreatmentFRK1Manufactureraccessdata.fda.gov
Chair, Surgical, Ac-PoweredGBB1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Chair, Surgical, Non-ElectricalFZK1Manufactureraccessdata.fda.gov
Chisel (Osteotome)KDG1Repackager or relabeleraccessdata.fda.gov
Chisel, MastoidJYD1Repackager 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
Clamp, Ossicle HoldingJYF1Repackager or relabeleraccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Repackager or relabeleraccessdata.fda.gov
Crutch, PtosisHJZ1Repackager 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, Surgical, DentalEMK1Repackager or relabeleraccessdata.fda.gov
CystotomeHNY1Repackager or relabeleraccessdata.fda.gov
Depressor, Metal Tongue, SurgicalKBL1Repackager or relabeleraccessdata.fda.gov
Device, Medical Examination, Ac PoweredKZF1Repackager or relabeleraccessdata.fda.gov
Dilator, LachrymalHNW1Repackager or relabeleraccessdata.fda.gov
Dilator, NasalLWF1Repackager or relabeleraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Repackager or relabeleraccessdata.fda.gov
Dissector, TonsilKBM1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Repackager or relabeleraccessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceERL2Repackager or relabeleraccessdata.fda.gov
Dropper, EntKCM1Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
Elevator, EntKAD1Repackager or relabeleraccessdata.fda.gov
Excavator, EarJYH1Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Forceps, EntKAE1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Repackager or relabeleraccessdata.fda.gov
Forceps, OphthalmicHNR1Repackager or relabeleraccessdata.fda.gov
Forceps, Wire Closure, Ent, Non-SterileNNQ1Repackager or relabeleraccessdata.fda.gov
Fork, TuningGWX1Repackager or relabeleraccessdata.fda.gov
Gag, MouthKBN1Repackager or relabeleraccessdata.fda.gov
Gauge, MeasuringJYJ1Repackager or relabeleraccessdata.fda.gov
Gouge, Nasal, EntKAQ1Repackager or relabeleraccessdata.fda.gov
Gouge, Surgical, General & Plastic SurgeryGDH1Repackager or relabeleraccessdata.fda.gov
Handle, ScalpelGDZ1Repackager or relabeleraccessdata.fda.gov
Headlamp, Operating, Battery-OperatedHPP1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Headlight, Fiberoptic FocusingFCT2Repackager or relabeleraccessdata.fda.gov
Headrest, NeurosurgicalHBM1Repackager or relabeleraccessdata.fda.gov
Holder, Camera, SurgicalFXR1Repackager 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, Tonsil SuturingKBP1Repackager or relabeleraccessdata.fda.gov
Inserter, Myringotomy TubeJYM1Repackager or relabeleraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Repackager 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, DisposableKDC1Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Repackager or relabeleraccessdata.fda.gov
Keratoscope, Battery-PoweredHLR1Repackager or relabeleraccessdata.fda.gov
Knife, EarJYO1Repackager or relabeleraccessdata.fda.gov
Knife, EntKTG1Contract manufacturer, Repackager 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, TonsilKBQ1Repackager or relabeleraccessdata.fda.gov
Lamp, Surgical, IncandescentGBC2Repackager or relabeleraccessdata.fda.gov
Laryngoscope, NasopharyngoscopeEQN2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Laryngoscope, RigidCCW1Repackager or relabeleraccessdata.fda.gov
LaryngostroboscopeEQL1Repackager or relabeleraccessdata.fda.gov
Lens, Camera, SurgicalFXQ1Repackager or relabeleraccessdata.fda.gov
Lens, Fresnel, Flexible, DiagnosticHJJ1Manufactureraccessdata.fda.gov
Loop, WireJYQ1Repackager or relabeleraccessdata.fda.gov
Loupe, Diagnostic/SurgicalFSP1Repackager or relabeleraccessdata.fda.gov
MalletHXL1Repackager or relabeleraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Repackager or relabeleraccessdata.fda.gov
Marker, ScleraHMQ1Repackager or relabeleraccessdata.fda.gov
Medical Device Data SystemOUG1Repackager or relabeleraccessdata.fda.gov
Microscope, SurgicalEPT1Repackager or relabeleraccessdata.fda.gov
Mirror, EntKAI1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Mirror, Headband, OphthalmicHKF1Repackager or relabeleraccessdata.fda.gov
Mirror, MouthEAX1Repackager or relabeleraccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Repackager or relabeleraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Repackager or relabeleraccessdata.fda.gov
Needle, Aspiration And Injection, ReusableGDM1Repackager or relabeleraccessdata.fda.gov
Needle, Suturing, ReusableGDL1Repackager 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
OtoscopeERA1Repackager or relabeleraccessdata.fda.gov
Pick, Microsurgical EarJYT1Repackager or relabeleraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Repackager or relabeleraccessdata.fda.gov
Probe, EntKAK1Repackager or relabeleraccessdata.fda.gov
Probe, LachrymalHNL1Repackager or relabeleraccessdata.fda.gov
Protector, DentalBRW1Repackager or relabeleraccessdata.fda.gov
Pump, Nebulizer, Electrically PoweredJPW1Repackager or relabeleraccessdata.fda.gov
Pump, Nebulizer, ManualEPN1Repackager or relabeleraccessdata.fda.gov
Punch, AdenoidKBS1Repackager or relabeleraccessdata.fda.gov
Punch, AntrumKAW1Repackager or relabeleraccessdata.fda.gov
Punch, Corneo-ScleralHNJ1Repackager or relabeleraccessdata.fda.gov
Punch, EntKTF1Repackager or relabeleraccessdata.fda.gov
Punch, NasalKAY1Repackager or relabeleraccessdata.fda.gov
Rasp, NasalKBA1Repackager or relabeleraccessdata.fda.gov
Retinoscope, Battery-PoweredHKM1Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Repackager or relabeleraccessdata.fda.gov
Retractor, EntKAL1Repackager or relabeleraccessdata.fda.gov
Rongeur, MastoidJZA1Repackager or relabeleraccessdata.fda.gov
Rongeur, NasalKBB1Repackager or relabeleraccessdata.fda.gov
Saw, NasalKBC1Repackager or relabeleraccessdata.fda.gov
Scissors, EarJZB1Repackager 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, Wire Cutting, Ent, SterileJYA1Repackager or relabeleraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Repackager or relabeleraccessdata.fda.gov
Snare, NasalKBE1Repackager or relabeleraccessdata.fda.gov
Snare, TonsilKBZ1Repackager or relabeleraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Repackager or relabeleraccessdata.fda.gov
Speculum, EntEPY1Repackager or relabeleraccessdata.fda.gov
Splint, Intranasal SeptalLYA1Repackager or relabeleraccessdata.fda.gov
Splint, NasalEPP1Repackager or relabeleraccessdata.fda.gov
Spoon, EarJZE1Repackager or relabeleraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Repackager or relabeleraccessdata.fda.gov
Sterilizer, SteamFLE2Repackager or relabeleraccessdata.fda.gov
Stethoscope, ElectronicDQD2Repackager or relabeleraccessdata.fda.gov
Support, Head, Surgical, EntEPW1Repackager or relabeleraccessdata.fda.gov
Syringe, EntKCP1Repackager or relabeleraccessdata.fda.gov
Syringe, Irrigating (Dental)EIB1Repackager or relabeleraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Repackager or relabeleraccessdata.fda.gov
Tonometer, Ac-PoweredHKX2Repackager or relabeleraccessdata.fda.gov
TonsillectomeKCA1Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Repackager or relabeleraccessdata.fda.gov
Trephine, Manual, OphthalmicHRH1Repackager or relabeleraccessdata.fda.gov
Trocar, EntKTE1Repackager or relabeleraccessdata.fda.gov
Trocar, SinusKBG1Repackager or relabeleraccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Repackager or relabeleraccessdata.fda.gov
Tube, Ear SuctionJZF1Repackager or relabeleraccessdata.fda.gov
Tube, TympanostomyETD2Repackager or relabeleraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Repackager or relabeleraccessdata.fda.gov
Unit, Examining/Treatment, EntETF1Manufactureraccessdata.fda.gov
Weights, Eyelid, ExternalMML2Repackager 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
June 21, 2019K181260MiiS Horus Scope DPT 100HKXSubstantially EquivalentMedimaging Integrated Solution, Inc (Miis)accessdata.fda.gov
November 16, 2018K180528InstruSafe(R) Sterilization ContainerKCTSubstantially EquivalentSummit Medical, Inc.accessdata.fda.gov
September 11, 2018K182196Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-StethDQDSubstantially EquivalentImediplus, Inc.accessdata.fda.gov
October 6, 2017K170470Digital Eye Anterior CameraHJOSubstantially EquivalentMedimaging Integrated Solution, Inc (Miis)accessdata.fda.gov
September 28, 2012K120982DIGITAL EYE-FUNDUS CAMERAHKISubstantially EquivalentMedimaging Integrated Solutions, Inc. (Miis)accessdata.fda.gov
July 12, 2006K061058NEOZOLINE VENTILATION TUBESETDSubstantially EquivalentAdept Medical, Ltd.accessdata.fda.gov
January 27, 2003K021750LID CHAIN EYELID WEIGHTSMMLSubstantially EquivalentJedmed Instrument Co.accessdata.fda.gov
November 24, 1998K982667MICROMEDICS NASAL SEPTAL BUTTONLFBSubstantially EquivalentMicromedics, Inc.accessdata.fda.gov
October 29, 1997K973550TUTTNAUER TABLE-TOP AUTOCLAVEFLESubstantially EquivalentTuttnauer U.S.A Co, Ltd.accessdata.fda.gov
May 17, 1993K921770ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/MGEISubstantially EquivalentElmed, Inc.accessdata.fda.gov
February 22, 1990K896961HALUX EXLITE MINOR SURGERY LIGHTGBCSubstantially EquivalentJedmed Instrument Co.accessdata.fda.gov
May 13, 1982K821181FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE #EQNSubstantially EquivalentMachida America, Inc.accessdata.fda.gov
March 25, 1982K820526RELIEF VALVE-HONAN INTRAOC. PRESSURELCCSubstantially EquivalentThe Lebanon Corp.accessdata.fda.gov
November 27, 1979K792159FISCH DRILL SYSTEMERLSubstantially EquivalentJedmed Instrument Co.accessdata.fda.gov

Compare with other makers

Updated June 21, 2019. 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.