BEUDAMED
    228 results · 29ms · 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 ×

    Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.

    FDA Enforcement
    Class II ·Ongoing·Resource Optimization & Innovation Llc·November 29, 2017

    Regard, Item Number: 800533002 Sterile, GS0606B - Abdominal PK - Westover Hills

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800527002 Sterile, OR0611B - Hip Shoulder PK - Westover Hills

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800555001, Sterile, HT0644A - Pediatric Card Cath - Childrens Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800568005, Sterile, OR0658E - Titanium Rib - Childrens Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800551003, Sterile, GS0640C - Lap Chole - Medical Center Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 880327008, Sterile, CV0758H - Open Heart A&B - OSU

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - Cabrini

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover Hills

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800558001, Sterile, OR0647A - Extremity - Childrens Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017