BEUDAMED
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    UNINHIBITED

    FDA 510(k)
    FDA Class 2 ·Dental

    PAQ.215X280X300.M9402-030.

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763010531·

    ROLLO 215X25X16E.CARDIOCARE

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763005780·

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0315030·Probe, 1.5 inch Ball, Steffee, Curved, Impaction

    METAL SCREW ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    M-H HA/PC 11X160MM T1

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·December 16, 2015

    M-H SOLID SHELL HA/PC DIA54MM LN24

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·March 1, 2016

    MALLORY-HEAD SHORT FEMORAL STEM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MEH·July 28, 2017

    MALLORY-HEAD ACETABULAR SHELL 54MM POUROUS + HAP COATED

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MEH·August 11, 2016

    BARD FLAT MESH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·March 8, 2013

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·February 16, 2011

    AFFINITY BED

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code HDD·March 26, 2008

    MLRY-HD XR LAT POR FMRL 8MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 24, 2020

    PRECISE PRO RX CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIM·March 20, 2013

    REFLECTION CONSTRAINED ACETABULAR LINER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KWZ·June 8, 2025

    M-H HA/PC 12X165MM T1

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·December 16, 2015

    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

    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