BEUDAMED
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    POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    TB

    FDA UDI
    Oscor Inc.·00836559009870·

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036018726·

    ULTRAPOWER

    FDA UDI
    Conmed Corporation·10845854023938·ULTRAPOWER NEURO GUARD, LONG

    A8 INTEGR8® Porous Pedicle Screw System

    FDA UDI
    ALLUMIN8, INC.·00850080772973·Torque Handle, 12 Nm

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100190·SNII Tap, 7.50mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710310200190·Talar Osteotmy Guide, 20mm x 19mm

    RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SINGLE SIZE TENDON SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 25, 2013

    DRILL, AO SMALL 4.2 X 300 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·March 9, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC INC·Product code NQP·March 27, 2008

    TPRLC 133 FP TYPE1 PPS SO 5.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·May 5, 2020

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·December 16, 2019

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·March 27, 2020

    PROLENE BLUE 0.7M 60CM W/NDL

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAW·March 11, 2020

    Instructions For Use document of the GPS Trackers.

    FDA Enforcement
    Class II ·Terminated·Blue Ortho·November 4, 2020

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 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