BEUDAMED
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    EXPEDIUM SYSTEM, VIPER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743571·LEVAMED ANKLE SUPPORT SILVER VI

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158216693·FORCEPS STANDARD DRESSING STRAIGHT 6.25"

    Aspida

    FDA UDI
    ALPHATEC SPINE, INC.·00190376116006·16mm SACRAL PLATE, TF

    Leva® Anterior Interbody System

    FDA UDI
    Spine Wave, Inc.·10840642117868·Modular Spacer, 34 mm (W) x 28 mm (L) x 9 mm (H...

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023994·PADDLE SPREADER, 16MM

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102160·Shaver, Open 16mm

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 9, 2022

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AUDIT MICROCV PROTEIN LINEARITY SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PRECISION®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 13, 2013

    DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SANTIAGO·Product code KPO·September 23, 2014

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·May 20, 2011

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 4, 2022

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC·Product code GJS·July 14, 2017

    TMJ Components: Right Ramus Component - DelCristo Catalog: 09-11-0215, TMJ - Shah Catalog: 09-42-0217, 09-11-0217. Left Fossa Component - DelCristo Catalog 09-42-0216, Left Ramus Component - DelCristo Catalog: 09-11-0216.

    FDA Recall
    Terminated ·Endotec, Inc.·Product code JWH·June 5, 2009

    ADULT BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 18, 2012

    TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). .

    FDA Enforcement
    Class II ·Terminated·TomoTherapy Incorporated·August 27, 2014

    Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.

    FDA Enforcement
    Class II ·Terminated·Accuray Incorporated·January 3, 2018

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016