BEUDAMED
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    MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Ophthalmic Scissors

    FDA UDI
    KATENA PRODUCTS, INC.·00841668105337·WESTCOTT TENOTOMY SCISSORS LEFT

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07310K0131100·Rod Inserter, Fixed, 90 Degree, MIS

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0131100·Assembly, Rod Inserter, Fixed UNID

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0131100·Rocker, One Piece

    MEDCOMP BIO-CATH CATHETER LINE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ANISEIKONIA INSPECTOR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SCORPIO PS TIB INSERT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDIC MAHWAH·Product code MBH·June 6, 2012

    2027971-2022-043110

    FDA Adverse Event
    Injury ·NOBEL BIOCARE USA, LLC·Product code DZE·February 18, 2022

    EPD 60000 RPM

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·June 27, 2017

    FLEXTEND II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 9, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·August 27, 2014

    VITALITY DR

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    DRILL BIT Ø1.8 F/MATMAND L125 2FLUTE F/0

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code DZI·September 3, 2013

    CABLE 3M TO CONSOLE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 16, 2014

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 2025

    i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code JGS·February 15, 2011

    PKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    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

    Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017