FDA Registration
Active
🇺🇸 United States
DSM Biomedical, Inc.
Reg #: 2530154
·
FEI: 1000307073
·
Expires 2026
Products
29
Proprietary Names
18
Establishment Types
2
Classifications
29
Registration Details
- Registration Name
- DSM Biomedical, Inc.
- Registration Number
- 2530154
- FEI Number
- 1000307073
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 735 Pennsylvania Dr
- City
- EXTON
- State
- PA
- ZIP
- 19341
- Country
- US
Regulatory Submissions
- 510(k) Number
- K071237
Owner / Operator
- Firm Name
- DSM BIOMEDICAL
- Operator Number
- 9020253
- Address
- 735 PENNSYLVANIA DRIVE, --
- City
- Exton
- State
- PA
- Postal Code
- 19341
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2012-11-07 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2012-02-28 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-01-22 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2013-01-22 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2013-01-22 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2013-01-22 |
| Barrier, Animal Source, Intraoral | NPL | Class 2 | Dental | No | 2016-06-14 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2022-11-04 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2011-12-05 |
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | Class 2 | General, Plastic Surgery | No | 2009-11-10 |
| Mesh, Surgical, Collagen, Staple Line Reinforcement | OXE | Class 2 | General, Plastic Surgery | No | 2009-11-10 |
| Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | PAJ | Class 2 | General, Plastic Surgery | No | 2009-11-10 |
| Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction | OXB | Class 2 | General, Plastic Surgery | No | 2009-11-10 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2009-11-10 |
| Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | OWY | Class 2 | General, Plastic Surgery | No | 2009-11-10 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2013-01-09 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2013-01-25 |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | Class 2 | Hematology | No | 2015-03-26 |
| Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair | QNI | Class 2 | Orthopedic | No | 2021-11-15 |
| Filler, Bone Void, Synthetic Peptide | NOX | Class 3 | Unknown | No | 2025-07-01 |
| Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation | OIS | Class 2 | Orthopedic | No | 2023-03-22 |
| Bone Grafting Material, Animal Source | NPM | Class 2 | Dental | No | 2017-05-17 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2012-11-12 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2013-01-22 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2011-12-05 |
| Plate, Cranioplasty, Preformed, Alterable | GWO | Class 2 | Neurology | No | 2011-12-05 |
| Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | PAG | Class 2 | General, Plastic Surgery | No | 2010-07-22 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2013-01-22 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2013-01-25 |
Proprietary Names
Meso Wound Matrix
xenoPATCH
Resolve Matrix Acellular Peritoneum Matrix
DSM Biomedical Porcine Pericardium Dental Membrane
Medeor Matrix
Medeor Tendon Matrix
Delivery Needle
Meso Tendon Matrix
JEN Device
DSM Biomedical Calcium Phosphate Cement
DSM Dental Bone Graft
COPIOS BONE VOID FILLER
DSM Dental Bone Graft Plus
PEAK PRP System
DSM Biomedical PRP Device
Meso Dental Membrane
Epi-Guide Bioresorb Barrier Matrix
Delivery Syringe and Needle
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)