FDA Registration
Active
🇺🇸 United States
SPECTRA MEDICAL DEVICES, LLC
Reg #: 1224960
·
FEI: 3000204727
·
Expires 2026
Products
21
Proprietary Names
27
Establishment Types
4
Classifications
21
Registration Details
- Registration Name
- SPECTRA MEDICAL DEVICES, LLC
- Registration Number
- 1224960
- FEI Number
- 3000204727
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 299 Ballardvale St Ste 1
- City
- WILMINGTON
- State
- MA
- ZIP
- 01887
- Country
- US
Regulatory Submissions
- 510(k) Number
- K163292
Owner / Operator
- Firm Name
- SPECTRA MEDICAL DEVICES, LLC
- Operator Number
- 9012618
- Address
- 299 BALLARDVALE STREET, SUITE 1
- City
- Wilmington
- State
- MA
- Postal Code
- 01887
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2017-12-27 |
| Saline, Vascular Access Flush | NGT | Class 2 | General Hospital | No | 2025-12-02 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2023-09-05 |
| Set, Anesthesia, Paracervical | HEE | Class 2 | Obstetrics/Gynecology | No | 2009-12-18 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2008-06-09 |
| Needle, Spinal, Short Term | MIA | Class 2 | Anesthesiology | No | 2008-06-09 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2008-12-15 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2008-06-09 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2023-09-05 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2008-05-13 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2015-01-26 |
| Generator, Lesion, Radiofrequency | GXD | Class 2 | Neurology | No | 2008-06-09 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2008-06-09 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2008-06-09 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2008-12-15 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2012-03-10 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2011-09-20 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2009-12-18 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2009-12-18 |
| Needle, Gastro-Urology | FHR | Class 1 | General, Plastic Surgery | No | 2020-12-21 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2008-06-09 |
Proprietary Names
SPECTRA Sonic Block Chiba Needle
SPECTRA Sonic Block Quincke Needle
SPECTRA Sonic Block Crawford Needle
SPECTRA Sonic Block Tuohy Needle
Spectra Epidural Needles
Epidural Anesthesia Needle
SPECTRA MSK Ultrasonic Injection Needle
SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
Sodium Chloride Inj. 0.9% USP 5ml and 10ml Ampule
VITREQ Cannula D253552
Cervical Regional Anesthesia Needle
Vascular Access Port Infusion Set
Spectra Spinal Needles
Spinal Needles (various)
Glass LOR Syringe
Vascular Access Port Huber Point Infusion Needle
VITREQ Needle D253554
Instrument,Manual,Surgical, General
Spectra Soft Tissue Biopsy Needles
SPECTRA Disposable Radio Frequency (RF) Needle
NBD Disposable RF Cannula
Disposable Epidural Anesthesia Tray
Spectra Guidewire Introducer Needle
Disposable Scalpel, One-Piece, Non-Sterile
Sponge Applicator
Introducer Needle
Atraumatic Pencil Point Spinal Needle
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device