BEUDAMED
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    BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032432·Baltic Denture System BDLoad Sm6 PLSEbm6DFs B3 ...

    MODIFICATION TO CLEARFIL PHOTO BOND

    FDA 510(k)
    FDA Class 2 ·Dental

    STRATO X

    FDA 510(k)
    FDA Class 2 ·Dental

    CUSTOM COMBI SET FRES2008 POST

    FDA Adverse Event
    Injury ·ERIKA DE REYNOSA·Product code FJK·May 15, 2000

    CUSTOM COMBI SET FRES2008 POST

    FDA Adverse Event
    Injury ·ERIKA DE REYNOSA·Product code FJK·May 15, 2000

    CUSTOM COMBI SET FRES2008 POST

    FDA Adverse Event
    Death ·ERIKA DE REYNOSA·Product code FJK·May 15, 2000

    A-V COMBISET 24/CS

    FDA Adverse Event
    Injury ·ERIKA DE REYNOSA·Product code FJK·August 31, 2000

    HT70 VENTILATOR

    FDA Adverse Event
    Injury ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·March 29, 2013

    SYSTEM, ADJUSTABLE GASTRIC BANDING

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·March 11, 2011

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FNL·April 16, 2008

    EVOLUT FX VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025

    FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    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

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016