BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    ADEL MEDICAL BIRTHING BED, MOD. LD-400

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Symmetry YASARGIL

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482031285·SUCTION TUBE 3.5 MM

    SURE-SNAP

    FDA UDI
    Gc Orthodontics America Inc.·E53580162200001·SURE-SNAP 1. MOLAR UPR RGT SZ 22

    ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNIVERSAL CLAMP STAINLESS STEEL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 23, 2012

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 25, 2007

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026