10,000 results
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48ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ESTEEM
FDA Adverse Event
Injury
·ENVOY MEDICAL CORP.·Product code OAF·December 13, 2017
CARELINK ENCORE
FDA Adverse Event
Malfunction
·PLEXUS MANUFACTURING SDN. BHD·Product code KRG·April 7, 2016
DIRECTLINK ICP MODULE
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code GWM·July 10, 2025
DIRECTLINK ICP EXTENSION CABLE
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code GWM·July 10, 2025
DIRECTLINK ICP EXTENSION CABLE
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code GWM·July 10, 2025
CERELINK ICP PROBE BASIC KIT
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES MANSFIELD·Product code GWM·July 10, 2025
CERELINK ICP PROBE BASIC KIT
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES MANSFIELD·Product code GWM·July 10, 2025
BRAVO CF REFLUX CAPSULE DELIVERY
FDA Adverse Event
Injury
·GIVEN IMAGING INC. / GIVEN IMAGING LTD.·Product code FFT·November 7, 2025
FOCUS RADIATION TREATMENT PLANNING SYSTEM
FDA Adverse Event
Malfunction
·COMPUTERIZED MEDICAL SYSTEMS, INC.·Product code KPQ·March 9, 1998
FOCUS RTP SYSTEM
FDA Adverse Event
Malfunction
·COMPUTERIZED MEDICAL SYSTEMS·Product code MUJ·July 22, 1998
XIO RTP SYSTEM
FDA Adverse Event
Malfunction
·COMPUTERIZED MEDICAL SYSTEMS, INC.·Product code KPQ·April 20, 2006
CXC FFT-1 NON-TILT STAT RADIO XRAY TAB 4 WA FL TAB
FDA 510(k)
FDA Class 2
·Radiology
ESTEEM
FDA Adverse Event
Malfunction
·ENVOY MEDICAL·Product code OAF·January 16, 2018
MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System 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 Recall
Terminated
·Integra LifeSciences Corp.·Product code JXG·April 8, 2019
LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME EVD 20ML LimiTorr INS9030 INS-9030 LIMITORR VOLUME LIMITING EVD 30 ML LimiTorr INS9030SP1 INS-9030SP1 LIMITORR VOLUME LIMITING EVD 30 ML Product Usage: The LimiTorr External CSF Drainage and Monitoring Systems provides a closed system for the CSF from the ventricles of the brain or the lumbar subarachnoid space to an external drainage bag. The LimiTorr volume limiting external CSF drainage system was designed to include a volume limiting valve mechanism which reduces the chances for excessive CSF drainage. The burette in the volume limiting external CSF drainage system contains a volume limiting valve which stops drainage when the pre-determined volume (20ml-30ml) is reached. Indications: The LimiTorr 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 in patients with infected CSF shunts, and to monitor ICP.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code JXG·April 8, 2019
DIRECTLINK ICP MODULE
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code GWM·July 10, 2025
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 Recall
Terminated
·Integra LifeSciences Corp.·Product code JXG·April 8, 2019
ALLURA XPER FD20
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·July 11, 2023
BRAVO
FDA Adverse Event
Injury
·ARIZONA DEVICE MANUFACTURING·Product code FFT·September 21, 2007
BRAVO
FDA Adverse Event
Malfunction
·ARIZONA DEVICE MANUFACTURING·Product code FFT·July 25, 2008