ELMED, INC.

FDA Device Registration & Listing · Glendale Heights, IL, US · Registration 1412854

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1412854
FEI Number
1412854
Entity Name
ELMED, INC.
City/State/Country
Glendale Heights, IL, US
Establishment Address
35 N Brandon Dr, Glendale Heights, IL 60139, US
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
ELMED, INC. (Owner Number: 1412854)
Owner / Operator Contact Address
35 N BRANDON DRIVE., --, Glendale Heights, IL 60139, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ESU 100 MEDI-MATIC RIGID LARYNGOSCOPE ELMED ELMED RONGEUR FORCEPS ELMED ELMED ELMED ELMED SPECULUM ELMED ELMED SCISSORS ELMED Laparoscopic Instruments and Accessories ELMED SEILER ESU 120 M/M DIGITAL ELMED ELMED ELMED ELMED ORTHOPAEDIC INSTRUMENTS MANUAL ENT INSTRUMENT VENTRICULAR CANNULA ELMED ELMED ELMED Shunt Guide ELMED LBC 50-P ACCESSORIES FOR ENDOSCOPES ENDOSCOPIC ACCESSORIES ELMED CLIP APPLIER LAPAROSCOPIC INSTRUMENTS ELMED ELMED DUAL ELMED-SINGLE ENDOSCOPE RIGID GENERAL INSTRUMENTS ELEKTROTOM/ESU ELMED HEADLIGHTS ELMED F1 EXAMINATION CHAIR ELMED ELMED ELMED ELMED ESU 70 SERIES SYSTEM ELMED

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2023-05-15
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-24
BWN Table And Attachments, Operating-Room General, Plastic Surgery Class 1 878.4950 1977-12-16
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2018-05-02
HTE Elevator General, Plastic Surgery Class 1 878.4800 2022-07-13
EMH Forceps, Rongeur, Surgical Dental Class 1 872.4565 1992-07-22
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 1992-07-22
HTX Rongeur Orthopedic Class 1 888.4540 2017-05-18
GAE Snare, Surgical General, Plastic Surgery Class 1 878.4800 1977-12-16
EME Punch, Biopsy, Surgical Dental Class 1 872.4565 1992-07-22
HOE Caliper, Ophthalmic Ophthalmic Class 1 886.4350 1992-07-22
FFQ Speculum, Rectal Gastroenterology, Urology Class 1 876.4730 1977-12-16
FRK Chair, Examination And Treatment General Hospital Class 1 880.6140 2007-11-24
HDL Retractor, Vaginal Obstetrics/Gynecology Class 1 884.4520 2023-02-14
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2021-02-03
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2019-04-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-04-02
FKC Clamp, Cannula Gastroenterology, Urology Class 1 876.5540 2023-06-20
EPT Microscope, Surgical General, Plastic Surgery Class 1 878.4700 1992-07-22
DYC Vectorcardiograph Cardiovascular Class 2 870.2400 2023-10-25
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 2024-09-13
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-24
EMD Hemostat, Surgical Dental Class 1 872.4565 1992-07-22
JOK Scissors, Medical, Disposable General Hospital Class 1 880.6820 1992-07-22
EML Chisel, Bone, Surgical Dental Class 1 872.4565 1992-07-22
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 1992-07-22
BRX Stool, Anesthesia Anesthesiology Class 1 868.6700 2022-07-13
HDQ Dilator, Cervical, Fixed Size Obstetrics/Gynecology Class 1 884.4530 2024-04-01
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2016-12-15
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2022-07-13
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2015-08-26
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2023-07-19
FXM Camera, Still, Endoscopic General, Plastic Surgery Class 1 878.4160 2023-03-09
DZN Instruments, Dental Hand Dental Class 1 872.4565 2023-12-19
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2016-12-14
HCD Cannula, Ventricular Neurology Class 1 882.4060 2016-09-07
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 1992-07-22
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 1992-07-22
FNY Basin, Emesis General Hospital Class 1 880.6730 2023-08-22
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 1992-07-22
PIY Stainless Steel Instrument, Shunt System Implantation Neurology Class 1 882.4545 2021-03-26
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 1992-07-22
HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4150 2007-11-24
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2017-12-07
GDC Table, Operating-Room, Electrical General, Plastic Surgery Class 1 878.4960 2012-01-12
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2023-01-26
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-02-16
NWV Laparoscopic Accessories, Gynecologic Obstetrics/Gynecology Class 1 884.1720 2016-03-03
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 1992-07-22
HSO Saw General, Plastic Surgery Class 1 878.4800 1992-07-22
EQH Source, Carrier, Fiberoptic Light Ear, Nose, Throat Class 1 874.4350 1992-07-22
GCM Endoscope, Rigid Gastroenterology, Urology Class 2 876.1500 2019-03-01
GEE Brush, Biopsy, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2017-06-09
BWA Unit, Electrosurgical And Coagulation, With Accessories General, Plastic Surgery Class 2 878.4400 2007-11-24
HPP Headlamp, Operating, Battery-Operated Ophthalmic Class 1 886.4335 2023-04-05
FHM Apparatus, Suturing, Stomach And Intestinal General, Plastic Surgery Class 1 878.4800 2012-08-07
ETF Unit, Examining/Treatment, Ent Ear, Nose, Throat Class 1 874.5300 2018-12-29
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2023-02-16
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1992-07-22
HDE Hook, Fibroid, Gynecological Obstetrics/Gynecology Class 1 884.4520 2025-03-07
FSP Loupe, Diagnostic/Surgical General, Plastic Surgery Class 1 878.4800 1992-07-22
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2023-03-10
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 1992-07-22
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 1992-07-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-03-25
NWW Hysteroscope Accessories Obstetrics/Gynecology Class 1 884.1690 2007-11-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ELMED, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0144-2024 Covidien 1
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024 Covidien 1
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024 Covidien 1
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0027-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1412854. Last updated year: 2026. Please use registration number 1412854 when referencing this establishment in official correspondence.
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