BEUDAMED
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    VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033469804·

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132150·Trial, TLIF, 27L OB CRV 7Deg, 15mm

    INSET 30

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 18, 2025

    BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CLEANAIR/ CLEANWATER UNIT, MODEL 1600

    FDA 510(k)
    FDA Class 1 ·Dental

    GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 2+ R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 27, 2022

    DEPUY ASR XL FEM IMP SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·March 20, 2013

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·March 8, 2011

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·March 14, 2008

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·August 7, 2024

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·December 10, 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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024