BEUDAMED
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    EMIT 2000 VANCOMYCIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Safco Micro Applicators

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310206923·Safco micro applicator uf pink 100POD

    THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COMPR 12MM IM HMRL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·April 1, 2019

    UNKNOWN

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·August 12, 2023

    PINNACLE ACETABULAR CUP SYSTEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS·Product code KWA·March 18, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 7, 2011

    9617604-2008-00031

    FDA Adverse Event
    Malfunction ·Product code JKA·February 29, 2008

    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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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