BEUDAMED
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    LAMBDA IMMAGE FREELITE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    Fiber Cable Assembly

    FDA UDI
    Candela Corporation·00817495021959·Fiber Assembly

    NGB-027 Needle-guided Bracket

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904097688·

    ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN LABELING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·February 11, 2013

    UNKNOWN ZIMMER FEMORAL HEAD

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDI·February 23, 2011

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code FZP·February 14, 2008

    OXF ANAT BRG LT XL SIZE 3 PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·September 1, 2021

    OXF UNI CMNTLS TIB SZ D LM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·September 1, 2021

    LIGHTSHEER EC

    FDA Adverse Event
    Injury ·RH USA, INC.·Product code GEX·August 28, 2012

    Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission. Through this network, a patient's data may be displayed at the bedside monitor, central station or clinical information system.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·September 26, 2012

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024