BEUDAMED
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    remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).

    FDA Enforcement
    Class II ·Terminated·Thermo Fisher·June 20, 2018

    remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).

    FDA Recall
    Terminated ·Thermo Fisher·Product code JTZ·May 4, 2018

    Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 6, 2016

    Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 6, 2016

    Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·August 3, 2016

    Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·August 3, 2016

    LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 114758 114759 114716 114717 114748 114749 114708 114709 114718 114719 CP561429 CP561430 CP561431 CP561432 CP561442 CP561449 CP561488 CP561489 CP561709 CP561710 CP561714 CP561715 PM555203 Product Usage: Total Elbow Replacement

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code PIX·August 21, 2019

    LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 114758 114759 114716 114717 114748 114749 114708 114709 114718 114719 CP561429 CP561430 CP561431 CP561432 CP561442 CP561449 CP561488 CP561489 CP561709 CP561710 CP561714 CP561715 PM555203 Product Usage: Total Elbow Replacement

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (BE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·February 12, 2014

    Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.

    FDA Recall
    Terminated ·Ceg Enterprises Llc·Product code MCF·April 5, 2016

    EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation

    FDA Enforcement
    Class II ·Terminated·EEG Info·December 26, 2012

    Assist Bed Rail - 6632

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·June 7, 2017

    EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation

    FDA Recall
    Terminated ·EEG Info·Product code HCC·November 15, 2012

    Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.

    FDA Enforcement
    Class II ·Terminated·Ceg Enterprises Llc·June 29, 2016

    GEN*S SlideMaker, Barcode Label Specifications, GEN*S SM Intended Use, GEN*S Slide and Sample, Part Numbers 6605360, P/N 4237221, 4237212, and 4277299. Intended for use as an optional peripheral to the COULTER GEN*S System. Creates a blood smear on a clean microscope slide using a segment of the blood sample aspirated by the GEN*S System.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code KPA·May 29, 2008

    COULTER LH SlideMaker, LH Barcode Specification, LH SM Intended Use, LH Slide and Sample Flow, Part Number 6605633, P/N 4277248, 4277299, and 277299. Intended for use as an optional peripheral to the Beckman Coulter LH 700 Series System. Creates a blood smear on a clean microscope slide using a segment of the blood sample aspirated by the LH 700 Series.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code KPA·May 29, 2008

    Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007. Sterilized using Ethylene Oxide. Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441 USA. The OptiSeal Valved PTFE Peelable Introducer is designed to reduce blood loss and air intake by providing hemostatic sealing at venous pressures. The device is offered in two configurations, one without a sideport and one with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock.

    FDA Recall
    Terminated ·Greatbatch Medical·Product code DYB·July 2, 2010

    00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM 00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM 00720505828 ACETAB.CUPW/SH,0DEG,28MMX58MM 00720506028 ACETAB.CUPW/SH,0DEG,28MMX60MM 00720506228 ACETAB.CUPW/SH,0DEG,28MMX62MM 00720506428 ACETAB.CUPW/SH,0DEG,28MMX64MM 00721004222 ACETAB.CUPW/SH,10DEG,22MMX42MM 00721004422 ACETAB.CUPW/SH,10DEG,22MMX44MM 00721005028 ACETAB.CUPW/SH,10DEG,28MMX50MM 00721005228 ACETAB.CUPW/SH,10DEG,28MMX52MM 00721005628 ACETAB.CUPW/SH,10DEG,28MMX56MM 00721006428 ACETAB.CUPW/SH,10DEG,28MMX64MM 00721006628 ACETAB.CUPW/SH,10DEG,28MMX66MM 00721006828 ACETAB.CUPW/SH,10DEG,28MMX68MM 00721007028 ACETAB.CUPW/SH,10DEG,28MMX70MM 00725504222 ACETAB.CUP, 0 DEG, 22MM X 42MM 00725504622 ACETAB.CUP, 0 DEG, 22MM X 46MM 00725504626 ACETAB.CUP, 0 DEG, 26MM X 46MM 00725504828 ACETAB.CUP, 0 DEG, 28MM X 48MM 00725505232 ACETAB.CUP, 0 DEG, 32MM X 52MM 00725505432 ACET CUP, 0 DEG, 32MM X 54MM 00725505632 ACET CUP, 0 DEG, 32MM X 56MM 00725505828 ACETAB.CUP, 0 DEG, 28MM X 58MM 00725505832 ACET CUP, 0 DEG, 32MM X 58MM 00725506028 ACETAB.CUP, 0 DEG, 28MM X 60MM 00725506032 ACET CUP, 0 DEG, 32MM X 60MM 00725506228 ACETAB.CUP, 0 DEG, 28MM X 62MM 00725506232 ACET CUP, 0 DEG, 32MM X 62MM 00725506428 ACETAB.CUP, 0 DEG, 28MM X 64MM 00725506432 ACET CUP, 0 DEG, 32MM X 64MM 00725506628 ACETAB.CUP, 0 DEG, 28MM X 66MM 00725506632 ACET CUP, 0 DEG, 32MM X 66MM 00725506828 ACETAB.CUP, 0 DEG, 28MM X 68MM 00725506832 ACET CUP, 0 DEG, 32MM X 68MM 00725507028 ACETAB.CUP, 0 DEG, 28MM X 70MM 00725507032 ACET CUP, 0 DEG, 32MM X 70MM 00726004222 ACETAB.CUP,10 DEG, 22MM X 42MM 00726004828 ACETAB.CUP,10 DEG, 28MM X 48MM 00726005028 ACETAB.CUP,10 DEG, 28MM X 50MM 00726005228 ACETAB.CUP,10 DEG, 28MM X 52MM 00726005232 ACETAB.CUP,10 DEG, 32MM X 52MM 00726005432 ACET CUP, 10 DEG, 32MM X 54MM 00726005632 ACET CUP, 10 DEG, 32MM X 56MM 00726005832 ACET CUP, 10 DEG, 32MM X 58MM 00726006032 ACET CUP, 10 DEG, 32MM X 60MM 00726006428 ACETAB.CUP,10 DEG, 28MM X 64MM 00726006432 ACET CUP, 10 DEG, 32MM X 64MM 00726006628 ACETAB.CUP,10 DEG, 28MM X 66MM 00726006632 ACET CUP, 10 DEG, 32MM X 66MM 00726006828 ACETAB.CUP,10 DEG, 28MM X 68MM 00726006832 ACET CUP, 10 DEG, 32MM X 68MM 00726007028 ACETAB.CUP,10 DEG, 28MM X 70MM 00726007032 ACET CUP, 10 DEG, 32MM X 70MM

    FDA Recall
    Terminated ·Zimmer Trabecular Metal Technology, Inc.·Product code LPH·April 15, 2016

    00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM 00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM 00720505828 ACETAB.CUPW/SH,0DEG,28MMX58MM 00720506028 ACETAB.CUPW/SH,0DEG,28MMX60MM 00720506228 ACETAB.CUPW/SH,0DEG,28MMX62MM 00720506428 ACETAB.CUPW/SH,0DEG,28MMX64MM 00721004222 ACETAB.CUPW/SH,10DEG,22MMX42MM 00721004422 ACETAB.CUPW/SH,10DEG,22MMX44MM 00721005028 ACETAB.CUPW/SH,10DEG,28MMX50MM 00721005228 ACETAB.CUPW/SH,10DEG,28MMX52MM 00721005628 ACETAB.CUPW/SH,10DEG,28MMX56MM 00721006428 ACETAB.CUPW/SH,10DEG,28MMX64MM 00721006628 ACETAB.CUPW/SH,10DEG,28MMX66MM 00721006828 ACETAB.CUPW/SH,10DEG,28MMX68MM 00721007028 ACETAB.CUPW/SH,10DEG,28MMX70MM 00725504222 ACETAB.CUP, 0 DEG, 22MM X 42MM 00725504622 ACETAB.CUP, 0 DEG, 22MM X 46MM 00725504626 ACETAB.CUP, 0 DEG, 26MM X 46MM 00725504828 ACETAB.CUP, 0 DEG, 28MM X 48MM 00725505232 ACETAB.CUP, 0 DEG, 32MM X 52MM 00725505432 ACET CUP, 0 DEG, 32MM X 54MM 00725505632 ACET CUP, 0 DEG, 32MM X 56MM 00725505828 ACETAB.CUP, 0 DEG, 28MM X 58MM 00725505832 ACET CUP, 0 DEG, 32MM X 58MM 00725506028 ACETAB.CUP, 0 DEG, 28MM X 60MM 00725506032 ACET CUP, 0 DEG, 32MM X 60MM 00725506228 ACETAB.CUP, 0 DEG, 28MM X 62MM 00725506232 ACET CUP, 0 DEG, 32MM X 62MM 00725506428 ACETAB.CUP, 0 DEG, 28MM X 64MM 00725506432 ACET CUP, 0 DEG, 32MM X 64MM 00725506628 ACETAB.CUP, 0 DEG, 28MM X 66MM 00725506632 ACET CUP, 0 DEG, 32MM X 66MM 00725506828 ACETAB.CUP, 0 DEG, 28MM X 68MM 00725506832 ACET CUP, 0 DEG, 32MM X 68MM 00725507028 ACETAB.CUP, 0 DEG, 28MM X 70MM 00725507032 ACET CUP, 0 DEG, 32MM X 70MM 00726004222 ACETAB.CUP,10 DEG, 22MM X 42MM 00726004828 ACETAB.CUP,10 DEG, 28MM X 48MM 00726005028 ACETAB.CUP,10 DEG, 28MM X 50MM 00726005228 ACETAB.CUP,10 DEG, 28MM X 52MM 00726005232 ACETAB.CUP,10 DEG, 32MM X 52MM 00726005432 ACET CUP, 10 DEG, 32MM X 54MM 00726005632 ACET CUP, 10 DEG, 32MM X 56MM 00726005832 ACET CUP, 10 DEG, 32MM X 58MM 00726006032 ACET CUP, 10 DEG, 32MM X 60MM 00726006428 ACETAB.CUP,10 DEG, 28MM X 64MM 00726006432 ACET CUP, 10 DEG, 32MM X 64MM 00726006628 ACETAB.CUP,10 DEG, 28MM X 66MM 00726006632 ACET CUP, 10 DEG, 32MM X 66MM 00726006828 ACETAB.CUP,10 DEG, 28MM X 68MM 00726006832 ACET CUP, 10 DEG, 32MM X 68MM 00726007028 ACETAB.CUP,10 DEG, 28MM X 70MM 00726007032 ACET CUP, 10 DEG, 32MM X 70MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Trabecular Metal Technology, Inc.·June 22, 2016

    14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10mm 7 deg 14 x 11 x 11mm 7 deg 14 x 11 x 12mm 7 deg Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.

    FDA Recall
    Terminated ·Spinal Solutions, LLC·Product code MNI·February 20, 2013