BEUDAMED
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    STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00531201·

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809844931·FOR MEN 20-30 MM HG KNEE HIGH OPEN TOE SMALL NA...

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981174095·L Con, Side-Loading, L, 16mm, 120mm

    MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C

    FDA 510(k)
    FDA Class 2 ·Hematology

    PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18

    FDA 510(k)
    FDA Class 2 ·Neurology

    ADVIA CENTAUR CKMB AND TROPONIN ULTRA ASSAY

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JHX·July 29, 2010

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·February 15, 2022

    I-STAT CARTRIDGE

    FDA Adverse Event
    Injury ·ABBOTT POINT OF CARE·Product code CHL·August 8, 2014

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 11, 2013

    PROXIMATE ILS CURVED CIR STAPL

    FDA Adverse Event
    Injury ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GDW·May 16, 2008

    DA+ C SERIES DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC S.A.·Product code DXY·April 13, 2011

    BD SAFETYGLIDE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·October 29, 2023

    REF H10

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·August 9, 2016

    ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020

    Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of standard curved suture needles, similar to open abdominal suturing.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 14, 2017

    i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code JGS·February 15, 2011

    GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. K900540: TRAM modules are intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The intended use of TRAM modules is to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. The TRAM module functions as a transport monitor during transport, and in the bedside monitor during ICU or OR monitoring. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. TRAM modules acquire, process and store information regarding these parameters. TRAM modules incorporate different monitoring capabilities based on their configuration. K011000: The TRAM 2001 Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The TRAM 2001 Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric, and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM 2001 Module functions in the bedside monitoring system. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. The TRAM 2001 Module acquires, processes and stores information regarding these parameters. The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctors office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport. K053121: The TRAM Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in its proper use. The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM Module functions in the bedside monitoring system. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and respiration. The TRAM Module acquires, processes and stores information regarding these parameters. The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctors office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·December 5, 2013

    Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428; Aquapak 728 SW, 760 ML W/028 Adaptor, Product No. 037-28; Aquapak SW/EAU Sterile, 760 ML W/Adaptor, Product No. 037-28C; Aquapak 728 SW, 760 ML W/28 Adaptor, French, Product No. 037-02F; Aquapak 733 SW, 760 ML W/033 Adaptor, Product No. 037-33; Aquapak 735 HNS, 760 ML W/028 Adaptor, Product No. 037-35; Aquapak 739 FNS, 760 ML W/028 Adaptor, Product No. 037-39; Aquapak 0.9% NACL, 760 ML W/Adaptor, Product No. 037-39C; Aquapak 770 HNS, 760 ML W/033 Adaptor, Product No. 037-70; Aquapak 1028 SW, 1070 ML W/028 Adaptor, Product No. 041-28; Aquapak SW/EAU Sterile, 1070 ML W/Adaptor, Product No. 041-28C; Aquapak 1033 SW, 1070 ML W/033 Adaptor; Product No. 041-33; Aquapak 1035 HNS, 1070 ML W/028 Adaptor, Product Code 041-35; Aquapak 428 SW, 440 ML W/028 Adaptor, Product No. 044-28; Aquapak SW/EAU Sterile, 440 MLW/Adaptor, Product No. 044-28C; Aquapak 428 SW, 440 ML W/028 Adaptor, French, Product No. 044-28F; Aquapak 433 SW, 440 ML W/033 Adaptor, Product No. 044-33; Aquapak 435 HNS, 440 ML W/028 Adaptor, Product No. 044-35; Aquapak 470 HNS, 440 ML W/033 Adaptor, Product No. 044-70. Used in anesthesiology.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 10, 2014

    GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. K900540: TRAM modules are intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The intended use of TRAM modules is to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. The TRAM module functions as a transport monitor during transport, and in the bedside monitor during ICU or OR monitoring. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. TRAM modules acquire, process and store information regarding these parameters. TRAM modules incorporate different monitoring capabilities based on their configuration. K011000: The TRAM 2001 Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The TRAM 2001 Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric, and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM 2001 Module functions in the bedside monitoring system. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. The TRAM 2001 Module acquires, processes and stores information regarding these parameters. The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctors office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport. K053121: The TRAM Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in its proper use. The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM Module functions in the bedside monitoring system. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and respiration. The TRAM Module acquires, processes and stores information regarding these parameters. The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctors office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·January 29, 2014