ENDOMED, LLC

FDA Device Registration & Listing · Orlando, FL, US · Registration 3016248634

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
3016248634
FEI Number
3016248634
Entity Name
ENDOMED, LLC
City/State/Country
Orlando, FL, US
Establishment Address
3505 Lake Lynda Dr, Suite 200, Orlando, FL 32817, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device
Owner / Operator
EndoMed, LLC (Owner Number: 10062249)
Owner / Operator Contact Address
1 Collins Place, Albany, NY 12208, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed Endomed

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HTD Forceps General, Plastic Surgery Class 1 878.4800 2024-08-20
GDT Staple, Removable (Skin) General, Plastic Surgery Class 1 878.4760 2020-01-07
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2024-08-20
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2024-08-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-08-20
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2020-01-02
GAD Retractor General, Plastic Surgery Class 1 878.4800 2020-01-02
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2020-07-05
FBM Cannula And Trocar, Suprapubic, Non-Disposable Gastroenterology, Urology Class 1 876.5090 2020-01-02
HBT Applier, Hemostatic Clip General, Plastic Surgery Class 1 878.4800 2020-01-02
QQS Stapler, Skin General Hospital Class 1 878.4740 2022-04-21
GDL Needle, Suturing, Reusable General, Plastic Surgery Class 1 878.4800 2020-01-02
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2020-01-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-11-05
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2020-01-02
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2024-08-20
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2020-03-20
FHO Pneumoperitoneum Needle Gastroenterology, Urology Class 2 876.1500 2023-11-05
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2023-11-05
NNQ Forceps, Wire Closure, Ent, Non-Sterile Ear, Nose, Throat Class 1 874.3540 2020-01-02
GDM Needle, Aspiration And Injection, Reusable General, Plastic Surgery Class 1 878.4800 2020-01-02
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2020-01-02
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2020-01-02
MNK Endoscopic Bite Block Gastroenterology, Urology Class 1 876.1500 2023-05-17
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2023-05-17
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-11-05
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2020-01-05
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2024-08-20
FCZ Tube, Smoke Removal, Endoscopic Gastroenterology, Urology Class 1 876.1500 2023-11-05
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2020-01-02
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-11-05
NWV Laparoscopic Accessories, Gynecologic Obstetrics/Gynecology Class 1 884.1720 2020-01-02
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2020-05-09
FBQ Trocar, Gastro-Urology Gastroenterology, Urology Class 2 876.5090 2023-05-17
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2020-01-02

Official Correspondent

Refaat Hafez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EndoMed, LLC
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
K852723 The Huxley Instrument Corp. FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 1985-07-15
K873512 Arthropedics, Inc. SERRATED GRASPING FORCEPS, RIGHT 1987-11-02
K220540 Covidien ProGrip Self-Gripping Polypropylene Mesh 2022-09-22
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

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-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0031-2014 Aesculap, Inc. 1
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0031-05 N/A 1
Hem-o-lok Endo5 Ligation Applier
Z-0001-2021 N/A 2
Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016248634. Last updated year: 2026. Please use registration number 3016248634 when referencing this establishment in official correspondence.
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