FDA Registration
Active
🇺🇸 United States
ENDOMED, LLC
Reg #: 3016248634
·
FEI: 3016248634
·
Expires 2026
Products
37
Proprietary Names
1
Establishment Types
3
Classifications
37
Registration Details
- Registration Name
- ENDOMED, LLC
- Registration Number
- 3016248634
- FEI Number
- 3016248634
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3505 Lake Lynda Dr, Suite 200
- City
- Orlando
- State
- FL
- ZIP
- 32817
- Country
- US
Regulatory Submissions
- 510(k) Number
- K142908
Owner / Operator
- Firm Name
- EndoMed, LLC
- Operator Number
- 10062249
- Address
- 1 Collins Place
- City
- Albany
- State
- NY
- Postal Code
- 12208
- Country
- US
- Correspondent
- Refaat Hafez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2024-08-20 |
| Staple, Removable (Skin) | GDT | Class 1 | General, Plastic Surgery | No | 2020-01-07 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2024-08-20 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2024-08-20 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2020-01-02 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2020-01-02 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-07-05 |
| Cannula And Trocar, Suprapubic, Non-Disposable | FBM | Class 1 | Gastroenterology, Urology | No | 2020-01-02 |
| Applier, Hemostatic Clip | HBT | Class 1 | General, Plastic Surgery | No | 2020-01-02 |
| Stapler, Skin | QQS | Class 1 | General Hospital | No | 2022-04-21 |
| Needle, Suturing, Reusable | GDL | Class 1 | General, Plastic Surgery | No | 2020-01-02 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2020-01-02 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2020-01-02 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Pneumoperitoneum Needle | FHO | Class 2 | Gastroenterology, Urology | No | 2023-11-05 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2023-11-05 |
| Forceps, Wire Closure, Ent, Non-Sterile | NNQ | Class 1 | Ear, Nose, Throat | No | 2020-01-02 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 2020-01-02 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2020-01-02 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2020-01-02 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2023-05-17 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2023-05-17 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-11-05 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2020-01-05 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2024-08-20 |
| Tube, Smoke Removal, Endoscopic | FCZ | Class 1 | Gastroenterology, Urology | No | 2023-11-05 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2020-01-02 |
| Laparoscopic Accessories, Gynecologic | NWV | Class 1 | Obstetrics/Gynecology | No | 2020-01-02 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2020-05-09 |
| Trocar, Gastro-Urology | FBQ | Class 2 | Gastroenterology, Urology | No | 2023-05-17 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2020-01-02 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2020-01-02 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2020-01-02 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2023-05-17 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2023-11-05 |
| Closure, Wound, Adhesive | MGO | Class 1 | General, Plastic Surgery | No | 2020-01-07 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2020-01-02 |
Proprietary Names
Endomed
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Device in the United States for Export Only