FDA Registration
Active
🇺🇸 United States
NORMED
Reg #: 3013226
·
FEI: 3013226
·
Expires 2026
Products
28
Proprietary Names
17
Establishment Types
1
Classifications
28
Registration Details
- Registration Name
- NORMED
- Registration Number
- 3013226
- FEI Number
- 3013226
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 4320 SOUTH 131ST PL., Suite 160
- City
- SEATTLE
- State
- WA
- ZIP
- 98168
- Country
- US
Regulatory Submissions
- 510(k) Number
- K081516
Owner / Operator
- Firm Name
- NORMED
- Operator Number
- 3013226
- Address
- 4310 SOUTH 131ST PL., --
- City
- Seattle
- State
- WA
- Postal Code
- 98168
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 1992-07-29 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 1992-07-29 |
| Ring Cutter | FNS | Class 1 | General Hospital | No | 1992-07-29 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2018-12-14 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 1992-07-29 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 1992-07-29 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2018-12-14 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2018-12-14 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2023-06-08 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 1992-07-29 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2018-12-14 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 1992-07-29 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2018-12-14 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2018-12-14 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2018-12-14 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 1992-07-29 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 1986-06-10 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2018-12-14 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2018-12-14 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 1992-07-29 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2018-12-14 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2020-12-02 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2018-12-14 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 1992-07-29 |
| Splint, Extremity, Inflatable, External | FZF | Class 1 | General, Plastic Surgery | No | 1992-07-29 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 1992-07-29 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 1992-07-29 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2018-12-14 |
Proprietary Names
MICROSHIELD
HANDLE
RING CUTTER
SCISSORS
TOURNIQUET
ankle brace
Splinter Aid splinter remover
RESCUE BLANKET
OXYGEN MASK
CPR MASK
WRISTPRO
FORCEPS
elbow brace
BURN GEL
BACKPRO
COLD PACK
cold pack
Establishment Types
Repack or Relabel Medical Device