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Data / Medical devices / United States / Elmed, Inc.

Elmed, Inc.: FDA-registered device maker in Glendale Heights, IL, United States, 8 510(k) clearances

Elmed, Inc. is registered with the FDA (registration 1412854) in Glendale Heights, IL, United States. It lists 83 device types. The FDA files 8 510(k) clearances under its listings, the newest dated March 22, 2019. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Elmed, Inc.
FDA registration number
1412854
Address
35 N Brandon Dr, Glendale Heights, IL, United States, 60139
Owner or operator
ELMED, INC. (1412854)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
December 16, 1977
Registered through
2026
Brand names listed
ACCESSORIES FOR ENDOSCOPES, BIOPSY FORCEPS, CLIP APPLIER, COHEN CANNULA, DUAL, ELEKTROTOM/ESU, ELMED, ELMED FORCEPS and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Repackager or relabeleraccessdata.fda.gov
Accessories, Cleaning Brushes, For EndoscopeMNL1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Apparatus, Suturing, Stomach And IntestinalFHM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Applier, Surgical, ClipGDO1Repackager or relabeleraccessdata.fda.gov
Basin, EmesisFNY1Repackager or relabeleraccessdata.fda.gov
Brush, Biopsy, General & Plastic SurgeryGEE1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Burr, OrthopedicHTT1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Caliper, OphthalmicHOE1Repackager or relabeleraccessdata.fda.gov
Camera, Still, EndoscopicFXM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cannula, Manipulator/Injector, UterineLKF2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cannula, VentricularHCD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Chair, Examination And TreatmentFRK1Repackager or relabeleraccessdata.fda.gov
Chair, Surgical, Ac-PoweredGBB1Repackager or relabeleraccessdata.fda.gov
Chisel (Osteotome)KDG1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Chisel, Bone, SurgicalEML1Repackager or relabeleraccessdata.fda.gov
Clamp, CannulaFKC1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)HIN2Manufactureraccessdata.fda.gov
Curette, Surgical, General UseFZS1Repackager or relabeleraccessdata.fda.gov
Curette, UterineHCY1Repackager or relabeleraccessdata.fda.gov
Diathermy, Shortwave, For Use In Applying Therapeutic Deep HeatIMJ2Repackager or relabeleraccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Manufacturer, Repackager or relabeleraccessdata.fda.gov
ElevatorHTE1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Endoscope, RigidGCM2Repackager or relabeleraccessdata.fda.gov
FileHTP1Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Repackager or relabeleraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Forceps, OphthalmicHNR1Repackager or relabeleraccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Repackager or relabeleraccessdata.fda.gov
Forceps, Surgical, GynecologicalHCZ2Repackager or relabeleraccessdata.fda.gov
Hammer, SurgicalFZY1Repackager or relabeleraccessdata.fda.gov
Headlamp, Operating, Battery-OperatedHPP1Repackager or relabeleraccessdata.fda.gov
Hemostat, SurgicalEMD1Repackager or relabeleraccessdata.fda.gov
Hook, Fibroid, GynecologicalHDE1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Hook, OphthalmicHNQ1Repackager or relabeleraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Hysteroscope AccessoriesNWW1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufacturer, Repackager 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, SurgicalEMF1Repackager or relabeleraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Laparoscopic Accessories, GynecologicNWV1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Laryngoscope, RigidCCW1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Loupe, Diagnostic/SurgicalFSP1Repackager or relabeleraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Microscope, SurgicalEPT1Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
OtoscopeERA1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Pliers, SurgicalHTC1Repackager or relabeleraccessdata.fda.gov
Probe, LachrymalHNL1Repackager or relabeleraccessdata.fda.gov
Punch, Biopsy, SurgicalEME1Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Retractor, VaginalHDL1Manufacturer, Repackager or relabeleraccessdata.fda.gov
RongeurHTX1Repackager or relabeleraccessdata.fda.gov
SawHSO1Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Repackager or relabeleraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Repackager or relabeleraccessdata.fda.gov
Scissors, OphthalmicHNF1Repackager or relabeleraccessdata.fda.gov
Scissors, Wire Cutting, Ent, SterileJYA1Repackager or relabeleraccessdata.fda.gov
Snare, SurgicalGAE1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Manufacturer, Repackager 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
Stainless Steel Instrument, Shunt System ImplantationPIY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Stimulator, NerveETN2Contract manufactureraccessdata.fda.gov
Stool, AnesthesiaBRX1Repackager or relabeleraccessdata.fda.gov
Surgical Instruments, G-U, Manual (And Accessories)KOA1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Table And Attachments, Operating-RoomBWN1Repackager or relabeleraccessdata.fda.gov
Table, Operating-Room, ElectricalGDC1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, SurgicalLRP1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Unit, Electrosurgical And Coagulation, With AccessoriesBWA2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Unit, Examining/Treatment, EntETF1Repackager or relabeleraccessdata.fda.gov
VectorcardiographDYC2Repackager 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
March 22, 2019K181173ELMED Laparoscopic Instruments and AccessoriesGCJSubstantially EquivalentElmed Incorporatedaccessdata.fda.gov
March 19, 1998K974793ELMED ESU 120 M/M DIGITALGEISubstantially EquivalentElmed, Inc.accessdata.fda.gov
November 15, 1994K926517ELMED LBC 50-PHINSubstantially EquivalentElmed, Inc.accessdata.fda.gov
May 2, 1994K932938ELMED ESU 300 M/M AND DIGITALGEISubstantially EquivalentElmed, Inc.accessdata.fda.gov
May 17, 1993K921770ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/MGEISubstantially EquivalentElmed, Inc.accessdata.fda.gov
November 5, 1992K915731ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITALGEISubstantially EquivalentElmed, Inc.accessdata.fda.gov
April 23, 1981K810529DIRECT WRITING VECTORCARDIOGRAPHDYCSubstantially EquivalentElmed, Inc.accessdata.fda.gov
December 7, 1978K781455SIEMENS ULTRATHERM 708IMJSubstantially EquivalentElmed, Inc.accessdata.fda.gov

Compare with other makers

Updated March 22, 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.