BEUDAMED
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    MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 16, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QJR·April 23, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QJR·April 16, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DAIGNOSTICS SCARBOROUGH, INC·Product code QJR·April 16, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QJR·April 16, 2021

    AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RUSCH SIMPLASTIC 3WAY 30CC 24F

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code KOD·February 25, 2013

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·February 24, 2011

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·April 3, 2008

    EMBRYO RPLCMNT CATHETER

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code MQF·September 24, 2019

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023

    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