16 results
·
15ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
×
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
FDA Enforcement
Class I
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·June 11, 2025
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A
FDA Enforcement
Class I
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·June 11, 2025
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU DYNJ44805M 3. CRANIOTOMY SKU CDS982719V CDS982719W DYNJ904168F DYNJ908404B DYNJ908723A DYNJ908723C 4. CRANIOTOMY #IMF 56646-LF SKU DYNJVB91001A 5. CRANIOTOMY CDS SKU CDS981888X CDS983467I 6. CRANIOTOMY PACK-LF SKU DYNJ09882G DYNJ09882I 7. CRANIOTOMY S NASSAU SKU DYNJ905879G 8. MHC CRANIOTOMY SKU DYNJ903713K DYNJ903713L 9. PAD CRANIOTOMY SKU DYNJ902149J
FDA Enforcement
Class I
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·June 11, 2025
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp.·August 3, 2022
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
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 Enforcement
Class I
·Terminated·Integra LifeSciences Corp.·May 29, 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 Enforcement
Class I
·Terminated·Integra LifeSciences Corp.·May 29, 2019
CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp.·December 20, 2023
CODMAN Disposable Perforator 11mm. Cranial Perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·November 12, 2025
CODMAN Disposable Perforator 9mm. Cranial Perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·November 12, 2025
Extended Tip Applicator 8CM, Box of 1.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·July 2, 2025
Extended Tip Applicator, 15 CM, Box of 5.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·July 2, 2025
Extended Tip Applicator, 8CM, Box of 5.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·July 2, 2025
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025
MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·July 2, 2025