BEUDAMED
    48 results · 9ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii ×

    PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE¿ HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.

    FDA Enforcement
    Class II ·Terminated·Ethicon Endo-Surgery Inc·January 16, 2019

    Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel colloidal gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids and supports autolytic debridement, and allows for non-traumatic removal. The product is an occlusive dressing, and does not require a secondary dressing.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·September 10, 2025

    Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel collodial gelling agent. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does require a secondary dressing.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·September 10, 2025

    TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

    FDA Enforcement
    Class II ·Ongoing·TriMed Inc.·November 20, 2019

    OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

    FDA Enforcement
    Class II ·Terminated·Orthohelix Surgical Designs Inc·October 17, 2012

    OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

    FDA Enforcement
    Class II ·Terminated·Orthohelix Surgical Designs Inc·October 17, 2012

    MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.

    FDA Enforcement
    Class II ·Terminated·Medrad Inc·February 27, 2013

    Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel colloidal gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does not require a secondary dressing.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·September 10, 2025

    Mini-Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description 31141479 K-1842-S OR Mini Kit 31141487 K-1560-S3 OR Mini Kit 31141495 K-1530-S3 OR Mini Kit 31141537 K-1940-S OR Mini Kit 31141552 K-1920-S OR Mini Kit 31141560 K-1200-S3 OR Mini Kit 31141578 K-1840-S OR Mini Kit 31141586 K-1660-S OR Mini Kit 31141602 K-1630-S OR Mini Kit 31141610 K-1615-S OR Mini Kit 31141628 K-1614-S OR Mini Kit 31141651 K-1560-S OR Mini Kit 31141669 K-1530-S OR Mini Kit 31141677 K-1200-S OR Mini Kit 31141784 K-1960-S OR Mini Kit 31141859 K-1615-S3 OR Mini Kit 31141875 K-1940-S3 OR Mini Kit 31145025 7496-8 MINI-PLUS KIT 31145397 7497-8 MINI-PLUS KIT 31145413 7497-88 Mini-Plus Kit 31150470 7496-PUP MINI PLUS KIT 50000148 K-1920-COE MINI-KIT 50047403 7496-HCS MINI-PLUS KIT 50047405 7496-HES MINI-PLUS KIT 573375A MINI-PLUS KIT

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·July 29, 2015

    HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·November 16, 2016

    Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·November 16, 2016

    ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·July 17, 2024

    LAPAROSCOPY PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 2015

    SHOULDER ARTHROSCOPY PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 2015

    OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 2015

    NEURO PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 2015

    OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 2015

    C-SECTION PK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 2015

    OPEN HEART PACK 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 2015