FDA Registration
Active
🇺🇸 United States
APPLIED MEDICAL RESOURCES CORP.
Reg #: 2027111
·
FEI: 2027111
·
Expires 2026
Products
30
Proprietary Names
4
Establishment Types
3
Classifications
30
Registration Details
- Registration Name
- APPLIED MEDICAL RESOURCES CORP.
- Registration Number
- 2027111
- FEI Number
- 2027111
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 22872 AVENIDA EMPRESA
- City
- RSM
- State
- CA
- ZIP
- 92688
- Country
- US
Regulatory Submissions
- 510(k) Number
- K103282
Owner / Operator
- Firm Name
- APPLIED MEDICAL RESOURCES
- Operator Number
- 2027111
- Address
- 22872 AVENIDA EMPRESA, --
- City
- Rancho Santa Margarita
- State
- CA
- Postal Code
- 92688
- Country
- US
- Correspondent
- Leilani - Domingo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ring (Wound Protector), Drape Retention, Internal | KGW | Class 2 | General, Plastic Surgery | No | 2020-12-18 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2011-06-08 |
| Catheter, Embolectomy | DXE | Class 2 | Cardiovascular | No | 2007-12-19 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2007-12-19 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2007-12-19 |
| Anoscope And Accessories | FER | Class 2 | Gastroenterology, Urology | No | 2017-12-11 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2007-12-19 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2013-11-21 |
| Culdoscope (And Accessories) | HEW | Class 2 | Obstetrics/Gynecology | No | 2019-09-13 |
| Illuminator, Non-Remote | FTF | Class 2 | General, Plastic Surgery | No | 2026-04-20 |
| System, Evacuator, Fluid | FHF | Class 2 | Gastroenterology, Urology | No | 2007-12-19 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2007-12-19 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2007-12-19 |
| Catheter, Ureteral, Gastro-Urology | EYB | Class 2 | Gastroenterology, Urology | No | 2007-12-19 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2007-12-19 |
| Adaptor, Ureteral Catheter | EYI | Class 1 | Gastroenterology, Urology | No | 2013-11-21 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2007-11-28 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2007-12-19 |
| Accessories, Catheter, G-U | KNY | Class 2 | Gastroenterology, Urology | No | 2007-12-19 |
| Stylet For Catheter, Gastro-Urology | EZB | Class 1 | Gastroenterology, Urology | No | 2007-12-19 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2000-04-18 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2002-12-11 |
| Vaginoscope And Accessories | MOK | Class 2 | Obstetrics/Gynecology | No | 2022-11-03 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2007-12-19 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2020-04-16 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2007-12-19 |
| Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | GCA | Class 2 | Gastroenterology, Urology | No | 2007-12-19 |
| Instrument, Manual, Specialized Obstetric-Gynecologic | KNA | Class 2 | Obstetrics/Gynecology | No | 2007-12-19 |
| Clip, Vascular | DSS | Class 2 | Cardiovascular | No | 2007-12-19 |
| Laparoscopic Accessories, Gynecologic | NWV | Class 1 | Obstetrics/Gynecology | No | 2012-02-07 |
Proprietary Names
GelPOINT Path Transanal Access Platform
Alexis® Lighted Wound Protector-Retractor
GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
GelPOINT Mini Advanced Access Platform
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)