161 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-102 CSF Drainage System w/Patient Line One Way Valve w MoniTorr 10110 10-110 CSF Drainage System used with Pole Mount System MoniTorr 10140 10-140 CSF Drainage System w/Vinyl Measuring Strip MoniTorr 10150 10-150 CSF Drainage System Simple Bag and Line MoniTorr 10110A 10-110A CSF Drainage System w/o Manifold Stopcock MoniTorr SP0017 SP0017 Special EVD 10-110 w/o Y Site Latex Free Sites MoniTorr SP0042 SP0042 Special EVD 10-100 w/o Y Site MoniTorr SP0090 SP0090 Special EVD 10-110 w/o Y Site MoniTorr SP0164 SP0164 Special EVD 10-140 w/Y Site & Stopcock Reverse MoniTorr SP0236 SP0236 INS 1100 WITH NEEDLE AT Y-ACCESS AND NEEDLELESS SI Product Usage: The MoniTorr ICP External CSF Drainage and Monitoring Systems provide a simple to use, closed system for the drainage of cerebrospinal fluid (CSF) from ventricles of the brain or the lumbar subarachnoid space to a drainage bag. The system may be used with a pole mounted assembly that allows for simple, quick and accurate alignment with the patient and secure positive or negative pressure level setting. The system also has been designed to provide for ease of patient transport through a compact design and antimicrobial hydrophobic vent feature that resists occlusion. Indications: The MoniTorr ICP system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF inpatients with infected CSF shunts, and to monitor ICP.
FDA Enforcement
Class I
·Terminated·Integra LifeSciences Corp.·May 29, 2019
VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.
FDA Enforcement
Class II
·Terminated·INNOKAS MEDICAL OY·February 4, 2015
Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·December 25, 2013
KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Recall
Terminated
·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code MQB·January 7, 2020
Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Recall
Terminated
·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code MQB·January 7, 2020
Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Recall
Terminated
·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code MQB·January 7, 2020
Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Recall
Terminated
·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code MQB·January 7, 2020
1.5 mm Inion CPS, Burrhole plate, REF PLT-1011, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
2.0 mm Inion CPS, 4 hole plate, REF PLT-1013, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
1.5 mm Inion CPS, 20 hole plate, REF PLT-1007, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
2.0 mm Inion CPS, 6 hole plate, REF PLT-1038, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
2.5 mm Inion CPS, 8 hole plate, REF PLT-1027, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
1.5 mm Inion CPS, 6 hole plate, REF PLT-1006, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
2.5 mm Inion CPS, 4 hole plate, REF PLT-1023, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
2.0 mm Inion CPS, 10 hole plate, REF PLT-1016, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
2.5 mm Inion CPS, 10 hole plate, REF PLT-1036, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
2.5 mm Inion CPS, 6 hole plate, REF PLT-1025, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
1.5 mm Inion CPS, 4 hole plate, REF PLT-1005, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
1.5 mm Inion CPS Baby, 4 hole plate, REF PLT-1000, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010
1.5 mm Inion CPS Baby , 2 hole plate, REF PLT-1004, sterile, Manufacturer, INION Oy, Finland.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010