BEUDAMED
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    ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatment of alveolar ridge -filling of defects after root resection, apicoectomy and cystectomy -Filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -Filling of periodontal defects in conjunction with products -Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.

    FDA Enforcement
    Class III ·Terminated·Collagen Matrix Inc·March 23, 2016

    NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) Manufacturer:- Collagen Matrix, Distributor:- ACE Surgical Supply Co, Inc, Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar ridge -filling of infrabony periodontal defects -filling of defects after root resection, apicoectomy and cystectomy -filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of pre-implant defects in conjunction with products intended for Guided Bone Regeneration

    FDA Enforcement
    Class II ·Terminated·Collagen Matrix Inc·March 23, 2016

    ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatment of alveolar ridge -filling of defects after root resection, apicoectomy and cystectomy -Filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -Filling of periodontal defects in conjunction with products -Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.

    FDA Recall
    Terminated ·Collagen Matrix Inc·Product code NPM·November 17, 2015

    a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only 20mm X 30mm REF 20650-02 6280-02 Rev.AE Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30C (86F) Do not re-use. CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

    FDA Recall
    Terminated ·Kensey Nash Corp·Product code NPL·February 28, 2012

    NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) Manufacturer:- Collagen Matrix, Distributor:- ACE Surgical Supply Co, Inc, Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar ridge -filling of infrabony periodontal defects -filling of defects after root resection, apicoectomy and cystectomy -filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of pre-implant defects in conjunction with products intended for Guided Bone Regeneration

    FDA Recall
    Terminated ·Collagen Matrix Inc·Product code NPM·May 13, 2013

    a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only 15mm X 20mm Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30C (86F) Do not re-use. CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

    FDA Recall
    Terminated ·Kensey Nash Corp·Product code NPL·February 28, 2012

    a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only 30mm X 40mm REF 20650-03 6280-03 Rev.AE Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30C (86F) Do not re-use. CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

    FDA Recall
    Terminated ·Kensey Nash Corp·Product code NPL·February 28, 2012

    Opti-Plast Balloon Dilatation Catheters

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code GBR·August 20, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-4515

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-5020

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-7020

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/2.0 cm/150 cm, Reference Catalog Number 38950-5020

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/2.0 cm/150 cm, Reference Catalog Number 38950-6020

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-4020

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.5 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-5520

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/ 2.0 cm/90 cm, Reference Catalog Number 37915-5020

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-6015

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-4020

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-4520

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-4515

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003