93 results
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Sources: EU EUDAMED, US FDA
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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 Recall
Open, Classified
·Integra LifeSciences Corp.·Product code GWM·October 5, 2023
Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBG·January 19, 2024
Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBG·January 19, 2024
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code FRO·September 13, 2024
SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBA·September 20, 2024
Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBG·October 19, 2023
Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBG·January 19, 2024
CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821749
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code JXG·May 7, 2024
Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code GWM·September 12, 2019
Ref No: INSHITH / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBG·January 19, 2024
Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: 31004
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBG·October 19, 2023
CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821750
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code JXG·May 7, 2024
Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBG·January 19, 2024
SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBA·September 20, 2024
SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBA·September 20, 2024
SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBA·September 20, 2024
SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBA·September 20, 2024
SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBA·September 20, 2024
MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID Material with x-ray detectable markers. All patties have a suture string attached for ease in performing postsurgical count verification. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBA·September 20, 2024
SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBA·September 20, 2024