BEUDAMED
    9 results · 27ms · 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 ×

    NATURA DENTURE TEETH

    FDA 510(k)
    FDA Class 2 ·Dental

    Brigade

    FDA UDI
    Nuvasive, Inc.·00887517967527·Brigade Lateral, 11x34x24mm 20°

    Polystar HK

    FDA UDI
    Merz Dental GmbH·D7091984134·anteriors; shade A3; mould 102

    MICRO-X 100CP

    FDA 510(k)
    FDA Class 1 ·Radiology

    POWER EXAMINATION TABLE MODEL # 411

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·February 28, 2013

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·February 10, 2011

    1.85MM X 16MM FLUTED ROUTER

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GFF·December 18, 2013

    Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the OPAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months or non-operative treatment. The OPAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS Including ClickX) and small stature USS.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016