BEUDAMED
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    GPF-29 GENERAL PURPOSE COIL SET

    FDA 510(k)
    FDA Class 2 ·Radiology

    Safco NiTi RL Rotary Files

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310208503·Safco NiTi RL rotary files, #30, (0.6 taper / 2...

    APC™ II Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221062857·Mini Uni-Twin(TM) Bracket APC(TM) II UR3 0T/11A...

    APC™ PLUS Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221093875·Mini Uni-Twin(TM) Bracket APC(TM) PLUS UR3 0T/1...

    POLESTAR N-10

    FDA 510(k)
    FDA Class 2 ·Radiology

    MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    EECP THERAPY SYSTEM, MODEL TS3

    FDA Adverse Event
    Injury ·VASOMEDICAL, INC.·Product code DRN·December 30, 2002

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 30, 2007

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·March 18, 2013

    CE INTERMATE SV 100, 48 PACK,50125

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·March 16, 2011

    LOGIC TIBIA PS MOD INSRT SZ 5 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 12, 2024

    ACHIEVE MAPPING CATHETER - 20 MM

    FDA Adverse Event
    Death ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code DRF·April 15, 2024

    ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Death ·MEDTRONIC CRYOCATH LP·Product code OAE·April 15, 2024

    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 Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018