BEUDAMED
    16 results · 20ms · 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.

    THERIGRAFT TCP PUTTY BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered in a syringe which is packaged in an aluminum-backed polyethylene pouch and is distributed one (1) pouch per box. The product affected by this recall was distributed by the recalling firm under six (6) different names. They are: Form-Putty; SBvFShape; Valeo BP; X-Putty; TheriGraft Putty; and SynFlow. The product is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and are intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The products are intended for use in defects of the skeletal system (i. e. the extremities, spine and pelvis).

    FDA Recall
    Terminated ·Theken Spine Llc·Product code NOX·August 26, 2010

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809842609·FOR MEN 30-40 MM HG KNEE HIGH OPEN TOE LARGE-LO...

    3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    FDA Adverse Event
    Malfunction ·MANNKIND CORPORATION - V-GO·Product code LZG·December 8, 2023

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP.·Product code DQX·October 16, 2009

    INCEPTA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013

    CONSULTA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·April 13, 2011

    SYNCHROMED EL

    FDA Adverse Event
    Malfunction ·RICE CREEK MANUFACTURING·Product code LKK·May 28, 2008

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·August 2, 2010

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·May 27, 2010

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·April 15, 2010

    SYNCHRO2-14 SUPPORT STRAIGHT 215CM

    FDA Adverse Event
    Malfunction ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 14, 2023

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·September 17, 2013

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012