BEUDAMED
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    MANDREL GUIDEWIRE ASSEMBLY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040013601·Zirlux 16+ A3 98.5X16

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01108T0·Cervical Trial, 14 x 11, 8mm, 7 Degree, Tapered

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01108N0·Cervical Trial, 14 x 11, 8mm, 0 Degree, No Taper

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 17, 2025

    REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP

    FDA 510(k)
    FDA Class 2 ·Neurology

    TRANS FX ADJUSTABLE PIN TO BAR CLAMP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INFUSAID IMPLANTABLE INFUSION PUMP

    FDA Adverse Event
    Injury ·STRATO/INFUSAID, INC.·Product code MDY·April 25, 1997

    ENDOCARE, CRYOCARE, CRYOPROBE

    FDA Adverse Event
    Malfunction ·HEALTHTRONICS, INC.·Product code GEH·April 2, 2012

    8CM HEAVY DUTY MEDIUM ATTACHMENT

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·March 14, 2013

    SACRAL CANNULATED POLYAXIAL SCREW 6.5MM X 35MM, TI

    FDA Adverse Event
    Injury ·ALPHATEC SPINE INC·Product code KWP·March 8, 2011

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

    PENTAX MEDICAL

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code EOQ·April 14, 2025

    PENTAX MEDICAL

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code EOQ·April 14, 2025

    PENTAX MEDICAL

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code EOQ·April 16, 2025

    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

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020