BEUDAMED
    13 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and

    FDA Enforcement
    Class II ·Ongoing·Cook Biotech, Inc.·January 22, 2025

    smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew Orthopaedics Ltd. (Aurora)·August 18, 2021

    Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (GG-122), CHROMIC GUT 2-0 75CM V20 X36 (GG-123), CHROMIC GUT 2-0 75CM V26 (GG-127), CHROMIC GUT 4-0 45CM P12 X36 (SG-5637), CHROMIC GUT 5-0 45CM P-13 X12 (SG-5687G), CHROMIC GUT 5-0 75CM CV23 (UG-202), CHROMIC GUT 4-0 75CM CV23 X36 (UG-203)

    FDA Enforcement
    Class II ·Ongoing·Covidien, LP·April 19, 2023

    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Product Usage: Hip joint prosthesis

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·September 16, 2015

    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·September 16, 2015

    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74120150 (50 MM), 74122150 (50 MM), 74122152 (52 MM), 74120152 (52 MM), 74120154 (54 MM) Product Usage: Hip joint prosthesis

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·September 16, 2015

    BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016

    BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016

    BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016

    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery

    FDA Enforcement
    Class II ·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012

    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery

    FDA Enforcement
    Class II ·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012

    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery

    FDA Enforcement
    Class II ·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012

    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery

    FDA Enforcement
    Class II ·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012