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Sign in to claim this brandCOLLAGEN MATRIX, INC.
United States·US-MF-000015783
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 15 Thornton Rd, Oakland, United States
- Website
- collagenmatrix.com
- —
- —
- [email protected]
- Phone
- (877) 540-3258
- PRRC Contact
- Peggy Hansen
- EUDAMED SRN
- US-MF-000015783
- FDA FEI Number
- 3008817245
- DUNS Number
- 176262442
Catalogue (727)
Page 14 of 15| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Neomem | N3040 | FDA UDI | Class II | Active |
| OsseoGuard Flex | OGF3040 | FDA UDI | Class II | Active |
| NeoGen Collagen Flex | 64051 | FDA UDI | Class II | Active |
| BoneSync BioActive | ABS-3500-40 | FDA UDI | Class II | Active |
| Cohealyx™ | BDCDM2035-5 | FDA UDI | U | Active |
| PreservaRidge™ Plug | PRPSLM | FDA UDI | Class II | Active |
| OsteoPlug™ | OGP0625 | FDA UDI | Class II | Active |
| OSTEO-Derm | OSTEOD15x20 | FDA UDI | Class II | Active |
| Cohealyx™ | BDCDM55 | FDA UDI | U | Active |
| Stratofuse | BA47-000005 | FDA UDI | Class II | Active |
| naturesQue MaxOss P | 58490 | FDA UDI | Class II | Active |
| PuraEXTEND | YSSPE30 | FDA UDI | Class II | Active |
| PlatFORM CM Block | CM25520 | FDA UDI | Class II | Active |
| AccuFuse | WMP05 | FDA UDI | Class II | Active |
| StarMem 4-6 | SM3040 | FDA UDI | Class II | Active |
| SMARTGRAFT Granules | 0114.112 | FDA UDI | Class II | Active |
| BoneSync BioActive | ABS-3400-02 | FDA UDI | Class II | Active |
| Neomem | N1520 | FDA UDI | Class II | Active |
| Stylos BA Putty | STYP005 | FDA UDI | Class II | Active |
| MaxxTape | XTAPE | FDA UDI | U | Active |
| Neogen Collagen Flex S | 64050 | FDA UDI | Class II | Active |
| Symbios | 32310000 | FDA UDI | Class II | Active |
| Symbios | 32310002 | FDA UDI | Class II | Active |
| BioMend | 0105Z | FDA UDI | Class II | Active |
| MatrixDerm Tape | BDDWDT2575 | FDA UDI | U | Active |
| Symbios | 32310005 | FDA UDI | Class II | Active |
| PlatFORM CM Putty | CM68902 | FDA UDI | Class II | Active |
| X-GEN Granules | PMC1020 | FDA UDI | Class II | Active |
| OsseoGuard | OG3040 | FDA UDI | Class II | Active |
| NeuroFlex | CNCF2525 | FDA UDI | Class II | Active |
| Porcine Mineral Collagen Composite Moldable | K201859 | FDA 510(k) | Class II | Active |
| Porcine Mineral Collagen Composite | K202183 | FDA 510(k) | Class II | Active |
| Mineral Collagen Composite Bioactive Extra Moldable | K231942 | FDA 510(k) | Class II | Active |
| Fibrillar Collagen Wound Dressing | K213341 | FDA 510(k) | U | Active |
| Bovine Dermis Collagen Dermal Matrix | K243071 | FDA 510(k) | U | Active |
| Collagen Wound Dressing - Oral | K040403 | FDA 510(k) | U | Active |
| Modification To: Collagen Topical Wound Dressing | K040558 | FDA 510(k) | U | Active |
| Reinforced Flexible Collagen Nerve Cuff | K170656 | FDA 510(k) | Class II | Active |
| Collagen Dental Membrane - Conformable Pp | K141909 | FDA 510(k) | Class II | Active |
| Anorganic Bone Mineral in Delivery Applicator | K170541 | FDA 510(k) | Class II | Active |
| Collagen Nerve Cuff | K012814 | FDA 510(k) | Class II | Active |
| Mineral Collagen Composite Bioactive Moldable | K221735 | FDA 510(k) | Class II | Active |
| Collagen Matrix Anorganic Bone Mineral Bone Graft Materials | K062200 | FDA 510(k) | Class II | Active |
| Collagen Dental Wound Dressings | K122115 | FDA 510(k) | U | Active |
| Synthetic Mineral-Collagen Bone Graft Matrix | K092608 | FDA 510(k) | Class II | Active |
| Duramatrix Collagen Dura Substitute Membrane | K040888 | FDA 510(k) | Class II | Active |
| Collagen Dental Wound Dressings | K033729 | FDA 510(k) | Class II | Active |
| Collagen Dental Membrane Iv | K090216 | FDA 510(k) | Class II | Active |
| Collagen Tendon Wrap | K080452 | FDA 510(k) | Class II | Active |
| Collagen Dura Membrane | K141608 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (15)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 3, 2022 | Z-1777-2022 | — | open, classified | The packaging may not be sealed, which could compromise sterility. |
| Dec 13, 2021 | Z-0668-2022 | — | terminated | Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery |
| Dec 13, 2021 | Z-0669-2022 | — | terminated | Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery |
| Nov 5, 2019 | Z-0909-2020 | — | terminated | The products may have been packaged with an incorrect Instructions for Use. |
| Nov 5, 2019 | Z-0910-2020 | — | terminated | The products may have been packaged with an incorrect Instructions for Use. |
| Nov 5, 2019 | Z-0908-2020 | — | terminated | The products may have been packaged with an incorrect Instructions for Use. |
| Nov 5, 2019 | Z-0907-2020 | — | terminated | The products may have been packaged with an incorrect Instructions for Use. |
| Nov 5, 2019 | Z-0912-2020 | — | terminated | The products may have been packaged with an incorrect Instructions for Use. |
| Nov 5, 2019 | Z-0911-2020 | — | terminated | The products may have been packaged with an incorrect Instructions for Use. |
| Mar 19, 2019 | Z-1389-2019 | — | terminated | Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box |
| Oct 30, 2018 | Z-0752-2019 | — | terminated | There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled. |
| Aug 16, 2018 | Z-0414-2019 | — | terminated | There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only difference between the two boxes is the product trade name. The label placed on the box and on the product packaged inside the box is correct. The Instructions for Use inside the box are correct. |
| Nov 17, 2015 | Z-1173-2016 | — | terminated | The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine. |
| Aug 25, 2015 | Z-1096-2016 | — | terminated | On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size. |
| May 13, 2013 | Z-1097-2016 | — | terminated | During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the compressed product fully expand within 1 minute of hydration time. |