FDA Registration
Active
🇺🇸 United States
F.M. HOWELL & CO.
Reg #: 1313700
·
FEI: 1313700
·
Expires 2026
Products
16
Proprietary Names
17
Establishment Types
1
Classifications
16
Registration Details
- Registration Name
- F.M. HOWELL & CO.
- Registration Number
- 1313700
- FEI Number
- 1313700
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 151 EAST FIFTH ST., P.O. BOX 286
- City
- ELMIRA
- State
- NY
- ZIP
- 14902
- Country
- US
Regulatory Submissions
- 510(k) Number
- K060859
- PMA Number
- BP120001
Owner / Operator
- Firm Name
- F.M. HOWELL & CO.
- Operator Number
- 1313700
- Address
- 151 EAST FIFTH ST., P.O. BOX 286
- City
- Elmira
- State
- NY
- Postal Code
- 14902
- Country
- US
- Correspondent
- KATHERINE H ROEHLKE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Cryosurgical, Accessories | GEH | Class 2 | General, Plastic Surgery | No | 2015-11-12 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2013-04-30 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2018-03-16 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2004-11-18 |
| Applicator, Vaginal | HGD | Class 1 | Obstetrics/Gynecology | No | 2018-08-29 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2020-03-30 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2013-02-01 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2013-01-22 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2013-01-22 |
| Pump, Infusion, Insulin | LZG | Class 2 | General Hospital | No | 2019-01-23 |
| Calculator, Drug Dose | NDC | Class 2 | Anesthesiology | No | 2019-01-23 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2013-01-22 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2018-03-16 |
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2013-01-22 |
| Test, Hiv Detection | MZF | Class 2 | Microbiology | No | 2012-08-10 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2020-12-28 |
Proprietary Names
Scholl
EXACTA-MED ORAL DISPENSER
BD PRECISION GLIDE NEEDLE
BIOJECT VIAL ADAPTER
Conceptrol
Clearblue Visual Pouched Preg Stick; Clearblue Rapid Detection Pregnancy Test
Instant-View
Histofreezer Device
Ophthalmic Specula
Ophthalmic Forceps
OMNIPOD PUMP, INFUSION, INSULIN
Sure Comfort Insulin Syringes
Dollar General Preg One Step Cassette; First Signal Pregnancy Cassette; Walmart First Signal Preg Cassette
EMERALD STERILE GAUZE PAD
Examination Gloves
OraQuick
BinaxNOW COVID-19 Ag Card HOME TEST
Establishment Types
Repack or Relabel Medical Device