BEUDAMED
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    IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·June 13, 2022

    MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE

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

    AVANTE CURELIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    EXTENSION SET WITH T-CONN. SL

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·October 3, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013

    8010042-2008-00070

    FDA Adverse Event
    Malfunction ·Product code CBK·May 30, 2008

    HIRES 90K

    FDA Adverse Event
    Injury ·ADVANCED BIONICS, LLC.·Product code MCM·May 3, 2011

    FIAB EURODEFIPADS

    FDA Adverse Event
    Malfunction ·FIAB S.P.A.·Product code LDD·October 19, 2022

    EURODEFIPADS

    FDA Adverse Event
    Malfunction ·FIAB SPA·Product code LDD·April 19, 2023

    DEFICOM

    FDA Adverse Event
    Malfunction ·FIAB SPA·Product code LDD·December 21, 2023

    Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). The system does not expose the patient to any ionizing radiation. The MRI Subsystem produces cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structures of the whole body. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient 's body (specific pharmaceuticals are used for whole body, brain, and other organ imaging). The PET and MRI portion of the system can be used either as an integrated system or as a stand-alone MRI or PET system. The MRI subsystem provides data suitable for use in attenuation correction of the PET acquired data.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code OUO·April 13, 2012

    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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Hemodialysis Delivery System, Software Version 2.x.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 2021

    Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015