21 results
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61ms
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Sources: EU EUDAMED, US FDA
GEMENI IGG ASSAY
FDA 510(k)
FDA Class 2
·Immunology
HEARTLINE NERVE VESSEL HOOK
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896070004·HEARTLINE NERVE & VESSEL HOOK BALL TIP
ACUMED
FDA UDI
Acumed LLC·10806378042249·Targeting Guide, Distal Clavicle Pl, L
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306835605·Basket Canula, aluminium handle 32cm, 5mm
FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNIBLATE ELECTROSURGICAL DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIODESIGN TENSION-FREE URETHRAL SLING
FDA Adverse Event
Injury
·COOK BIOTECH, INC.·Product code PAG·April 3, 2014
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·October 22, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 31, 2007
BD PLATE CAMPYLOBACTER SB 100MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code JSJ·June 2, 2022
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA Enforcement
Class II
·Terminated·BioHorizons Implant Systems Inc·December 26, 2012
Philips GoSafe Communicator 7000L Personal emergency response system.
FDA Recall
Terminated
·Lifeline Systems, Incorporated·Product code ILQ·April 22, 2015
Newport e360 Ventilator, Rx only. The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL).
FDA Recall
Terminated
·Newport Medical Instruments Inc·Product code CBK·December 15, 2008
Newport HT70 Ventilator. Model #HT70, The Newport HT70 ventilator is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or noninvasive interfaces. Specifically, the Newport HT70 ventilator is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 Ibs). The Newport HT70 ventilator is suitable for use in hospital, subacute, emergency room, and home care environments as well as for transport and emergency response applications.
FDA Recall
Terminated
·Newport Medical Instruments Inc·Product code CBK·September 20, 2010
Newport HT50 Ventilator. Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B. The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs)
FDA Recall
Terminated
·Newport Medical Instruments Inc·Product code CBK·May 14, 2010
Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.). The HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
FDA Recall
Terminated
·Newport Medical Instruments Inc·Product code CBK·August 3, 2012
Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces.
FDA Recall
Terminated
·Newport Medical Instruments Inc·Product code CBK·April 5, 2013
Newport HT50 Ventilator, Model # HT-50-H, HT50-HB, HT50-H1, and HT50-H1B Product Code: NOU The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22Ibs), who require the following general types of ventilatory support: positive pressure ventilation with Assist/Control, SIMV and SPONT/CPAP modes of ventilation. The NEWPORT HT50 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
FDA Recall
Terminated
·Newport Medical Instruments Inc·Product code CBK·July 22, 2009
V24-00400-29 cable, an accessory to the Newport HT50 ventilator. The V24-00400-29 cable is an accessory to the Newport HT50 ventilator intended to transfer the alarm signal from the ventilator to a nurse remote station.
FDA Recall
Terminated
·Flight Medical Ltd.·Product code CBK·August 10, 2011
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021