Collagen Matrix, Inc.
Collagen Matrix, Inc. holds FDA 510(k) medical device clearances, first cleared 2001, most recent 2025, with 15 FDA device recalls on record.
Top product codes for Collagen Matrix, Inc.
FDA recalls by Collagen Matrix, Inc.
10 most recent of 15- Z-1777-2022 — Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) MaxxTape, 2.5cm x 7.5cm x 0.1cm 4) NEOTAPE, 25mm x 75mm 5) Karl Schumacher TAPE, 2.5cm x 7.5cm x 1mm
- Z-0669-2022 — RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
- Z-0668-2022 — DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
- Z-0910-2020 — GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
- Z-0907-2020 — GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
- Z-0912-2020 — GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
- Z-0909-2020 — GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
- Z-0911-2020 — GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
- Z-0908-2020 — GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
- Z-1389-2019 — Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery. Neomem¿ is also intended for use in patients with moderate to severe periodontal disease as a material for placement in periodontal defects to aid in wound healing of periodontal tissue.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Collagen Matrix, Inc.
- K251191 — Collagen Dura Regeneration Membrane - Repair
- K243071 — Bovine Dermis Collagen Dermal Matrix
- K242302 — RejuvaKnee Collagen Meniscus Implant
- K233203 — Soft Tissue Augmentation Resorbable Matrix
- K240424 — Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix
- K231942 — Mineral Collagen Composite Bioactive Extra Moldable
- K221735 — Mineral Collagen Composite Bioactive Moldable
- K213341 — Fibrillar Collagen Wound Dressing
- K202183 — Porcine Mineral Collagen Composite
- K201859 — Porcine Mineral Collagen Composite Moldable
- K182074 — Mineral Collagen Composite Bioactive Moldable
- K171008 — Anorganic Bone Mineral with Collagen in Delivery Applicator
- K170541 — Anorganic Bone Mineral in Delivery Applicator
- K170656 — Reinforced Flexible Collagen Nerve Cuff
- K162158 — Porcine Anorganic Bone Mineral in Delivery Applicator
- K152600 — Collagen Dental Wound Dressings
- K150825 — Collagen Dural Regeneration Matrix
- K141608 — COLLAGEN DURA MEMBRANE
- K142496 — Collagen Dental Membrane - Conformable IIBP
- K141909 — COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP
- K140714 — PORCINE ANORGANIC BONE MINERAL
- K131541 — FLEXIBLE COOAGEN NERVE CUFF
- K122115 — COLLAGEN DENTAL WOUND DRESSINGS
- K110600 — COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN
- K100156 — COLLAGEN DENTAL MEMBRANE V
- K092608 — SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
- K090216 — COLLAGEN DENTAL MEMBRANE IV
- K083742 — SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
- K080452 — COLLAGEN TENDON WRAP
- K072397 — SYNOSS SYNTHETIC BONE GRAFT MATERIAL
- K062200 — COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS
- K062846 — COLLAGEN DENTAL MEMBRANE III
- K062881 — COLLAGEN DENTAL MENBRANE - CONFORMABLE II
- K060952 — COLLAGEN NERVE WRAP
- K061487 — DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE
- K052812 — OSSIMEND (TM) BONE GRAFT MATERIAL
- K052041 — COLLAGEN BONE HEALING PROTECTIVE SHEET
- K043034 — OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS
- K040888 — DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE
- K040403 — COLLAGEN WOUND DRESSING - ORAL
- K033729 — COLLAGEN DENTAL WOUND DRESSINGS
- K040558 — MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
- K040211 — MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
- K030921 — COLLAGEN TOPICAL WOUND DRESSING
- K012814 — COLLAGEN NERVE CUFF
- K011695 — COLLAGEN DENTAL MEMBRANE
- K003339 — COLLAGEN PERIODONTAL MEMBRANE
Data sourced from openFDA. This site is unofficial and independent of the FDA.