BEUDAMED
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    KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Woven Filiform Straight Tip

    FDA UDI
    C. R. Bard, Inc.·00801741073076·Woven Filiform Straight Tip

    Sterilance LDE3

    FDA UDI
    Sterilance Medical (Suzhou) Inc.·06945630112898·

    Sterilance LDE3 With AST Cap

    FDA UDI
    SteriLance Medical (Suzhou) Inc.·16945630108751·Sterilance LDE3 With AST Cap,1pcs/box

    LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEOCONTROL PELVIC FLOOR THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    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

    GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    MALLORY-HEAD ACETABULAR SHELL 54MM POUROUS + HAP COATED

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

    LINOX T 75

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVY·March 26, 2013

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 25, 2011

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·March 28, 2008

    MLRY-HD XR LAT POR FMRL 8MM

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

    ARTICULEZE M HEAD 36MM +12

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·January 18, 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

    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

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024