BEUDAMED
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    MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE

    FDA 510(k)
    FDA Class 2 ·Dental

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032750·Baltic Denture System BDLoad Mm6 PLSEbim6DFm BL...

    Fast ChromoProtector

    FDA UDI
    BIO SB, INC.·B502BSB0327500·Fast ChromoProtector is used in histological, i...

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180501207·SHARP COBB, DOWN-ANGLED 18MM

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180503805·SHARP COBB, DOWN ANGLED 12 MM

    HL168T

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADC PEDIATRIC

    FDA 510(k)
    FDA Class 2 ·Radiology

    MOSAIC

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·December 11, 2025

    WALLFLEX DUODENAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MUM·January 22, 2025

    ARCOM 28MM RNGLOC LNR HWALL 22

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·February 8, 2018

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 29, 2013

    TAXUS (R) LIBERTÉ (R)

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 29, 2011

    PALL ULTIPOR 100 BREATHING SYSTEM FILTER

    FDA Adverse Event
    Malfunction ·PALL NEWQUAY, LTD.·Product code CAH·April 24, 2008

    RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 27, 2018

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018