FDA Registration
Active
🇺🇸 United States
AMERICAN MEDICAL ENDOSCOPY
Reg #: 3004361445
·
FEI: 3004361445
·
Expires 2026
Products
34
Proprietary Names
4
Establishment Types
2
Classifications
34
Registration Details
- Registration Name
- AMERICAN MEDICAL ENDOSCOPY
- Registration Number
- 3004361445
- FEI Number
- 3004361445
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3020 NW 82ND AVE.
- City
- Doral
- State
- FL
- ZIP
- 33122
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173070
Owner / Operator
- Firm Name
- American Medical Endoscopy
- Operator Number
- 9059843
- Address
- 3020 NW 82ND AVE., --
- City
- Doral
- State
- FL
- Postal Code
- 33122
- Country
- US
- Correspondent
- Matthew K Schwimmer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2022-04-13 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2022-04-13 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2022-04-13 |
| Camera, Cine, Endoscopic, Without Audio | FWL | Class 1 | General, Plastic Surgery | No | 2024-08-02 |
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2023-11-28 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2022-09-21 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2022-04-13 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2013-12-31 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2013-12-31 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2013-12-31 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2024-05-01 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2024-11-21 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2023-08-23 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2022-09-21 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2022-06-22 |
| Trocar, Gastro-Urology | FBQ | Class 2 | Gastroenterology, Urology | No | 2022-09-21 |
| Urethrotome | EZO | Class 2 | Gastroenterology, Urology | No | 2022-04-13 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2024-08-29 |
| Lithotriptor, Biliary Mechanical | LQC | Class 2 | Gastroenterology, Urology | No | 2023-08-25 |
| Evacuator, Bladder, Manually Operated | FFD | Class 1 | Gastroenterology, Urology | No | 2022-04-13 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2024-10-29 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2019-12-16 |
| Needle, Gastro-Urology | FHR | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Obturator, For Endoscope | FEC | Class 2 | Gastroenterology, Urology | No | 2019-07-17 |
| Kit, Nephroscope | FGA | Class 2 | Gastroenterology, Urology | No | 2019-07-17 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2019-07-17 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2024-04-03 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2023-11-28 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2022-04-13 |
| Image, Illumination, Fiberoptic, For Endoscope | FFS | Class 2 | Gastroenterology, Urology | No | 2021-04-26 |
| Illuminator, Fiberoptic, Surgical Field | HBI | Class 2 | General, Plastic Surgery | No | 2021-04-26 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2022-06-27 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2024-04-03 |
Proprietary Names
Strauss Surgical
AME-4IN1-VIDN-SET
Strauss Surgical Cystoscopes & Hysteroscopes
Strauss Surgical cystoscope, hysteroscope and accessories Instruments
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility