FDA Registration
Active
🇺🇸 United States
BEAR-ENT, LLC
Reg #: 3021680161
·
FEI: 3021680161
·
Expires 2026
Products
60
Proprietary Names
2
Establishment Types
4
Classifications
60
Registration Details
- Registration Name
- BEAR-ENT, LLC
- Registration Number
- 3021680161
- FEI Number
- 3021680161
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 274 Lancaster Ave., Suite 208
- City
- Malvern
- State
- PA
- ZIP
- 19355
- Country
- US
Owner / Operator
- Firm Name
- BEAR-ENT, LLC
- Operator Number
- 10084364
- Address
- 274 Lancaster Ave., Suite 208
- City
- Malvern
- State
- PA
- Postal Code
- 19355
- Country
- US
- Correspondent
- David Y Burke
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scissors, Ear | JZB | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Holder, Ear Speculum | JYK | Class 1 | General, Plastic Surgery | No | 2022-05-03 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2023-07-24 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2025-03-10 |
| Press, Vein | JYW | Class 1 | Ear, Nose, Throat | No | 2026-05-19 |
| Punch, Adenoid | KBS | Class 1 | Ear, Nose, Throat | No | 2022-09-01 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2022-02-26 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2023-07-18 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2023-03-09 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2022-08-02 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Excavator, Ear | JYH | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2022-02-16 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 2024-03-20 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2022-02-26 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Forceps, Wire Closure, Ent, Non-Sterile | NNQ | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Punch, Antrum | KAW | Class 1 | Ear, Nose, Throat | No | 2022-02-14 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2022-04-20 |
| Snare, Ear | JZD | Class 1 | Ear, Nose, Throat | No | 2022-08-01 |
| Pick, Microsurgical Ear | JYT | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2022-03-31 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2022-02-26 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2022-02-23 |
| Cannula, Sinus | KAM | Class 1 | General, Plastic Surgery | No | 2022-02-27 |
| Rongeur, Nasal | KBB | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 2022-04-21 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2022-09-13 |
| Mobilizer, Ent | KAJ | Class 1 | Ear, Nose, Throat | No | 2023-04-23 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2022-08-17 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2022-08-17 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2022-02-26 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Rod, Measuring Ear | JYZ | Class 1 | Ear, Nose, Throat | No | 2023-07-26 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2022-08-02 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2022-02-26 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2022-02-26 |
| Snare, Nasal | KBE | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Curette, Ethmoid | KAO | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2022-09-25 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2023-03-28 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2022-02-25 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2024-05-21 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2022-02-26 |
| Punch, Ethmoid | KAX | Class 1 | Ear, Nose, Throat | No | 2022-02-26 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2025-03-16 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2022-07-20 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2022-02-26 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2024-01-31 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2022-02-26 |
| Block, Cutting, Ent, Non-Sterile | NNR | Class 1 | Ear, Nose, Throat | No | 2024-03-27 |
Proprietary Names
BEAR
GEIZ
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility