FDA Registration
Active
🇺🇸 United States
ANDERSEN SCIENTIFIC, INC.
Reg #: 1064858
·
FEI: 3008397795
·
Expires 2026
Products
68
Proprietary Names
50
Establishment Types
2
Classifications
68
Registration Details
- Registration Name
- ANDERSEN SCIENTIFIC, INC.
- Registration Number
- 1064858
- FEI Number
- 3008397795
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1001 Aviation Parkway, Suite 600
- City
- Morrisville
- State
- NC
- ZIP
- 27560
- Country
- US
Owner / Operator
- Firm Name
- ANDERSEN SCIENTIFIC, INC.
- Operator Number
- 9034670
- Address
- 1001 Aviation Parkway, Suite 600
- City
- Morrisville
- State
- NC
- Postal Code
- 27560
- Country
- US
- Correspondent
- DARYL - WOODMAN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tissue Adhesive For The Topical Approximation Of Skin | MPN | Class 2 | General, Plastic Surgery | No | 2022-03-08 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2026-03-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2021-04-29 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2015-12-30 |
| Shoulder Arthroplasty Implantation System | QHE | Class 2 | Orthopedic | No | 2025-05-09 |
| Electrode, Depth | GZL | Class 2 | Neurology | No | 2018-11-28 |
| Light, Surgical, Carrier | FSZ | Class 2 | General, Plastic Surgery | No | 2026-03-18 |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | Class 2 | Cardiovascular | No | 2026-03-18 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2026-03-18 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2012-12-11 |
| Intravenous Catheter Force-Activated Separation Device. | QOI | Class 2 | General Hospital | No | 2026-03-18 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2026-03-18 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2026-03-18 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2026-03-18 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2023-08-07 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2026-03-18 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2023-05-19 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2023-05-19 |
| Ophthalmic Syringe | QLY | Class 2 | General Hospital | No | 2023-05-19 |
| Tube, Gastro-Enterostomy | KGC | Class 2 | Gastroenterology, Urology | No | 2026-03-18 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2026-03-18 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2026-03-18 |
| System, Applicator, Radionuclide, Manual | IWJ | Class 1 | Radiology | No | 2026-03-18 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2021-04-29 |
| System, Skin Closure | MKY | Class 1 | General, Plastic Surgery | No | 2026-03-18 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2026-03-19 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2026-03-19 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2026-03-19 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2023-05-19 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2023-05-19 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2023-05-19 |
| Apparatus, Autotransfusion | CAC | Class 2 | Anesthesiology | No | 2026-03-18 |
| Aspiration Thrombectomy Catheter | QEZ | Class 2 | Cardiovascular | No | 2026-03-18 |
| Cutaneous Tissue Adhesive With Mesh | OMD | Class 2 | General, Plastic Surgery | No | 2022-03-08 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2021-04-29 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2026-03-18 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2026-03-18 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2026-03-19 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2018-11-28 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2018-11-28 |
| Filler, Bone Void, Non-Alterable Compound For Cranioplasty | PJN | Class 2 | Neurology | No | 2020-12-30 |
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | Class 2 | Neurology | No | 2020-12-30 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2026-03-18 |
| Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | OWY | Class 2 | General, Plastic Surgery | No | 2026-03-18 |
| Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon | OWW | Class 2 | General, Plastic Surgery | No | 2026-03-18 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2021-04-29 |
| Retractor, Fiberoptic | FDG | Class 1 | Gastroenterology, Urology | No | 2026-03-18 |
| Skin Resurfacing Rf Applicator | OUH | Class 2 | General, Plastic Surgery | No | 2018-11-28 |
| Peripheral Intravenous (Piv) Infiltration Monitor | PMS | Class 2 | General Hospital | No | 2022-03-08 |
| Catheter, Drainage, Intraoral/Extraoral | OAJ | Class 1 | General, Plastic Surgery | No | 2026-03-18 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2026-03-18 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2021-04-29 |
| Joint, Temporomandibular, Implant | LZD | Class 3 | Dental | No | 2026-03-18 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2026-03-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2021-04-29 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2018-11-29 |
| Retention Device, Suture | KGS | Class 1 | General, Plastic Surgery | No | 2026-03-18 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2018-11-29 |
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2023-05-19 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2021-04-29 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2026-03-23 |
| Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament | QWJ | Class 2 | General, Plastic Surgery | No | 2026-03-18 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2021-04-29 |
| Tube, Laryngectomy | KAC | Class 1 | Ear, Nose, Throat | No | 2012-12-11 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2023-05-19 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2018-11-28 |
| Snare, Flexible | FDI | Class 2 | Gastroenterology, Urology | No | 2019-12-09 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2026-03-18 |
Proprietary Names
CORE Shoulder System
AccuPoint Electrode
TracLux
Aventus Thrombectomy System
Stainless Steel Distraction Screw
Orchid Safety Release Valve
OSPREY Midline Closed IV Catheter System
Radical the Dude 7F Guide Catheter
Radical 7F Access Catheter
BNLE Access Guidewire
PUMA-G
NPWT Prevent Kit
Distraction screw
iWand
HEMIGARD Interlock
OSPREY Closed IV Catheter System
Optimotion Blue Knee System
Radical 8F Access Catheter
Radical the Dude 8F Guide Catheter
IOPS Fiducial Tracking Pad
IOPS Viewpoint Double Curve Catheter
IOPS Guidewire Handle
IOPS Guidewire 2
. IOPS Viewpoint Simple Curve Catheter
Tactix Vector Suture Kit
Luminelle DTx Hysteroscopy System
BioBrace(R)
PinXel-RF
TalWire Access Guidewire
Withrow Sialendoscopy
Schaitkin Salivary
Hemorrhage Occluder Pin
Hemorrhage Occluder Pin with Applicator
Orthotin TMJ Replacement
Symmetric Total Knee Augments
Profusion Needle
OSPREY PERIPHERAL IV Catheter System
HEMIGARD ADHESIVE RETENTION SUTURE DEVICE
Silicone Suction Cups
Ocular Conformers
Cornea Shields
Aventus Clot Management System
nanoMesh
Evala
Salivary ByPass Tube
StaClear Syringe
LIGHTFORCE 20/30 980nm Diode Laser
Smartsnare
Colorectal Air Syringe-OP
Colorectal Air Syringe-LP
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Device in the United States for Export Only