FDA Registration
Active
🇺🇸 United States
ARTISAN MEDICAL
Reg #: 3006591312
·
FEI: 3006591312
·
Expires 2026
Products
18
Proprietary Names
33
Establishment Types
1
Classifications
18
Registration Details
- Registration Name
- ARTISAN MEDICAL
- Registration Number
- 3006591312
- FEI Number
- 3006591312
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 55 Highbridge Blvd
- City
- Medford
- State
- NJ
- ZIP
- 08055
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061690
Owner / Operator
- Firm Name
- Artisan Medical
- Operator Number
- 10029903
- Address
- 55 Highbridge Blvd
- City
- Medford
- State
- NJ
- Postal Code
- 08055
- Country
- US
- Correspondent
- James J Lees Jr
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2017-04-12 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2013-06-26 |
| Speculum, Rectal | FFQ | Class 1 | Gastroenterology, Urology | No | 2013-06-26 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2014-02-12 |
| Laparoscopic Accessories, Gynecologic | NWV | Class 1 | Obstetrics/Gynecology | No | 2013-06-26 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2013-06-26 |
| Table, Surgical With Orthopedic Accessories, Manual | JEB | Class 1 | General, Plastic Surgery | No | 2019-06-13 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-06-26 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2015-03-11 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-11-13 |
| Retractor, Fiberoptic | FDG | Class 1 | Gastroenterology, Urology | No | 2013-06-26 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2013-06-26 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2013-06-26 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2013-06-26 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2013-06-26 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2013-01-14 |
| Hook, Gastro-Urology | FHB | Class 1 | Gastroenterology, Urology | No | 2013-06-26 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2019-02-20 |
Proprietary Names
IUD INSERTION KIT
Rosenblatt Surgical Caddy
Fiber Optic Light Cords
Rectal Spceulums
Hill Ferguson Rectal Retractors
LITE SPEC
brite spec
HALO SPECULUM
Laparoscopic Scope Warmer
Coated LLETZ Forceps
BiPolar Forceps
Adson Brown Forceps; Adson Dressing Forceps; Adson Forceps; Adson Tissue Forceps; Adson-Brown Tissue Forceps; Adson-DeBa
Lees Knee Holder
Rectal Blades, Meyerding Blades, Deaver Blades,
Iron Martin Arm
Wexler Retractor
Fan Retractor
Kelly Retractor, Malleable Retractor, Balfour Retractor, Rectal Retractor, Posterior and Anterior Retractor,
Snake Retractor
Charnely Retractor
Lucite Stent
Reusable Stainless Steel Pilot Guide
Heany Simon Lighted Retractor
Breisky Lighted Retractor
Miyazaki Lighted Retractor
St Marks Lighted Retractor
Hand Held Needle Holders
Graves, Pederson, Weisman-Graves, All Metal Speculums
LLETZ Coated Speculums
Baby Iris Scissors; Baby Lexer Scissors; Baby Metzenbaum Scissors; Cottle Scissors; Freeman Facelift Scissors; Freeman-K
Burke Biopsy Forceps; Eppendorfer Biopsy Forceps; Kevorkian Biopsy Forceps; Schubert Biopsy Forceps; Tischler Biopsy For
Artisan Suture Passer Joystick Suture Guide
Nathanson Hook Liver Retractor
Establishment Types
Repack or Relabel Medical Device