FDA Registration
Active
🇺🇸 United States
ACME UNITED CORP.
Reg #: 1025972
·
FEI: 1030186
·
Expires 2026
Products
29
Proprietary Names
10
Establishment Types
2
Classifications
29
Registration Details
- Registration Name
- ACME UNITED CORP.
- Registration Number
- 1025972
- FEI Number
- 1030186
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2280 Tanner Rd
- City
- Rocky Mount
- State
- NC
- ZIP
- 27801
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153496
Owner / Operator
- Firm Name
- ACME UNITED CORP.
- Operator Number
- 1217843
- Address
- 1 Waterview Drive
- City
- Shelton
- State
- CT
- Postal Code
- 06484
- Country
- US
- Correspondent
- Roberta C Bloom
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2019-01-23 |
| Thermometer, Clinical Color Change | FQZ | Class 1 | General Hospital | No | 2020-06-11 |
| Shoe And Shoe Cover, Conductive | BWP | Class 1 | General, Plastic Surgery | No | 2018-06-15 |
| Stretcher, Hand-Carried | FPP | Class 1 | General Hospital | No | 2023-07-07 |
| Finger Cot | LZB | Class 1 | General Hospital | No | 2017-01-27 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2011-11-05 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2016-04-11 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2018-06-15 |
| Splint, Extremity, Noninflatable, External, Sterile | FYH | Class 1 | General, Plastic Surgery | No | 2011-11-05 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2011-11-05 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2018-06-15 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 1992-07-30 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2017-05-31 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2016-04-11 |
| First Aid Kit With Drug | LRR | Class N | Unknown | No | 2017-05-31 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2017-06-29 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2011-11-05 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2016-04-25 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2011-11-05 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2018-01-05 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2016-08-11 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-12-14 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2011-09-15 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2016-08-11 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2016-08-11 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 1992-07-30 |
| Snake Bite Suction Kit | KYP | Class 1 | General Hospital | No | 2016-04-11 |
| Personal Protection Kit | PXC | Class 1 | General Hospital | No | 2020-09-16 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 1992-07-30 |
Proprietary Names
Scissors
Shoe Covers
Pac-Kit
First Aid Only
Finger Cot
Physicians Care
Physicans Care
First Aid Only Pac-Kit Physicians Care
Tongue depressor and finger splint
Physicians CAre
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device