FDA Registration
Active
🇺🇸 United States
Freudenberg Medical, LLC
Reg #: 2025182
·
FEI: 2025182
·
Expires 2026
Products
20
Proprietary Names
11
Establishment Types
3
Classifications
20
Registration Details
- Registration Name
- Freudenberg Medical, LLC
- Registration Number
- 2025182
- FEI Number
- 2025182
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1110 Mark Ave
- City
- CARPINTERIA
- State
- CA
- ZIP
- 93013
- Country
- US
Regulatory Submissions
- 510(k) Number
- K851082
Owner / Operator
- Firm Name
- Freudenberg Medical, LLC
- Operator Number
- 2025182
- Address
- Freudenberg Medical, LLC, 1110 Mark Avenue
- City
- Carpinteria
- State
- CA
- Postal Code
- 93013
- Country
- US
- Correspondent
- Rhonda Kops
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Nasopharyngeal | ENW | Class 1 | Ear, Nose, Throat | No | 2013-12-17 |
| Cup, Menstrual | HHE | Class 2 | Obstetrics/Gynecology | No | 2019-02-14 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 1998-07-24 |
| Tray, Surgical, Ent | MMO | Class 1 | Ear, Nose, Throat | No | 2014-03-28 |
| Implant, Absorbable, (Scleral Buckling Methods) | HQJ | Class 2 | Ophthalmic | No | 2020-05-29 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2013-01-29 |
| Pessary, Vaginal | HHW | Class 2 | Obstetrics/Gynecology | No | 2020-05-28 |
| Prosthesis, Laryngeal (Taub) | EWL | Class 2 | Ear, Nose, Throat | No | 2009-01-08 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2014-03-07 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 2009-10-08 |
| Button, Nasal Septal | LFB | Class U | Unknown | No | 2014-03-28 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2009-10-08 |
| Tube, Laryngectomy | KAC | Class 1 | Ear, Nose, Throat | No | 2013-12-17 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2025-03-14 |
| Implant, Intragastric For Morbid Obesity | LTI | Class 3 | Unknown | No | 2013-12-17 |
| Brush, Cleaning, Tracheal Tube | EPE | Class 1 | Anesthesiology | No | 2014-11-25 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2023-07-20 |
| Bone Cement, Antibiotic | MBB | Class 2 | Orthopedic | No | 2023-07-20 |
| Snare, Nasal | KBE | Class 1 | Ear, Nose, Throat | No | 2004-07-29 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2014-11-25 |
Proprietary Names
Blom-Singer Cleaning Brush
StageOne Knee Tibial Cement Spacer Mold, M/L 75mm, A/P 45mm
StageOne Knee Tibial Cement Spacer Mold, M/L 65mm, A/P 39mm
StageOne Knee Femoral Cement Spacer Mold, M/L 65mm, A/P 48mm
StageOne Knee Cement Spacer Mold
StageOne Knee Tibial Cement Spacer Mold, M/L 80mm, A/P 48mm
StageOne Knee Femoral Cement Spacer Mold, M/L 75mm, A/P 57mm
StageOne Knee Femoral Cement Spacer Mold, M/L 70mm, A/P 52mm
StageOne Knee Tibial Cement Spacer Mold, M/L 70mm, A/P 42mm
StageOne Knee Femoral Cement Spacer Mold, M/L 60mm, A/P 43mm
Blom-Singer Duckbill Voice Prosthesis
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility