BEUDAMED
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    FoundationOne CDx test report

    FDA Recall
    Terminated ·Foundation Medicine, Inc.·Product code PQP·August 8, 2019

    FoundationOne CDx test report

    FDA Enforcement
    Class II ·Terminated·Foundation Medicine, Inc.·December 4, 2019

    MicroSTAAR Injector, MSI-PF Packed ten per box.

    FDA Recall
    Terminated ·Staar Surgical Co Inc·Product code KYB·April 21, 2004

    MSI-EpiDermGlu (Iso-Butyl 2 Cyanoacrylate) tissue adhesive for soft tissue approximation; 0.22 cc plastic squeeze tubes packaged in a Tyvek/PPE pouch with paper label, 10 units per case; Manufactured by Medisav Services Inc. (MSI), 56 Elson Street, Markham, Ontario L3S 1Y7 Canada

    FDA Recall
    Terminated ·Elite Medical Group·Product code MPN--·July 3, 2003

    MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF

    FDA Recall
    Terminated ·Staar Surgical Co Inc·Product code KYB·February 23, 2004

    Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autosomal dominant condition known as Hereditary Non-Polyposis Colon Cancer (HNPCC).

    FDA Enforcement
    Class II ·Terminated·Leica Biosystems Richmond Inc.·September 20, 2017

    Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

    FDA Enforcement
    Class II ·Terminated·Anodyne Surgical·June 23, 2021

    Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

    FDA Recall
    Terminated ·Anodyne Surgical·Product code HMX·April 21, 2021

    5.0 mm Parafix Part Number 22-5011 is a suture anchor metal Intended for rotator cuff repair.

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code MBI·August 8, 2011

    OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor Intended for rotator cuff repair

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code HWC·August 8, 2011

    3.0mm 45 Degree Beval with cable Product Number AC2430-01 is an ablation wand

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code GEI·August 8, 2011

    Lancelot 90 Degree with Cable Part Number ASC4145-01 is an ablation wand

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code GEI·August 8, 2011

    OPUS SmartStitch M-Connector Product Number OM-8007 is a suture passer

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code KOG·August 8, 2011

    3.0 60 Degree wand Part Number A2530-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels.

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code GEI·August 8, 2011

    OPUS Magnum 2 Plus Implant Product Number OM-9026 is one of two kits Intended for rotator cuff repair.

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code MBI·August 8, 2011

    OPUS Magnum 2 Plus Implant Product Number OM-1502 is a bone anchor Intended for rotator cuff repair in the shoulder.

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code MBI·August 8, 2011

    OPUS Magnum 2 Plus Implant Product Number OM-9027 is one of two kits with product number OM-1502 Intended for rotator cuff repair

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code MBI·August 8, 2011

    OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor Intended to be used for fixation of soft tissue to bones

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code MBI·August 8, 2011

    SideWinder Hip Wand Product Number AC2340-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·August 8, 2011

    OPUS SmartStitch Product Number OM-8178 is a suture cartridge For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code KOG·August 8, 2011