BEUDAMED
    10 results · 26ms · 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 Regulation: Us FDA ×

    GLUMA DESENSITIZER/GLUMA 3 PRIMER

    FDA 510(k)
    FDA Class 2 ·Dental

    P.F.C. SIGMA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295244615·P.F.C. SIGMA STABILIZED PLUS TIBIAL INSERT TRIA...

    DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N

    FDA 510(k)
    FDA Class 1 ·Dental

    Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HARMONIC SYNERGY* DISSECTING HOOK WITH TORQUE WRENCH

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 4, 2014

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 14, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522RNAS

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·January 11, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 29, 2014

    Medtronic INTREPID Spinal System SPACER M 37X27, 8 DEG, Size 10MM, Part Number: REF 7962810; 12MM, REF 7962812; 14MM, REF 7962814; 16MM, REF 7962816; 18MM, REF 7962818; 20MM, REF 7962820; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease.

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code MAX·February 6, 2009

    Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" Used for the temporary relief of joint and muscle pain.

    FDA Enforcement
    Class II ·Terminated·Battle Creek Equipment Co.·November 9, 2016