Home › Device types › HBA
Neurosurgical Paddie
FDA product code HBA · Class 2 · Neurology
554
Registered devices
600
Adverse events
78
Recalls
24
510(k) clearances
Devices with this code
Spetzler Neuro Patties — OMT, LLCSpetzler Neuro Patties — OMT, LLCOMT LLC — OMT, LLCNEURAY ® — MEDTRONIC XOMED, INC.Spetzler Neuro Patties — OMT, LLCRay-Cot — AMERICAN SURGICAL COMPANY, LLCCODMAN — Cerenovus, Inc.ArmourSorb — AMERICAN SURGICAL COMPANY, LLCOMT LLC — OMT, LLCMEDLINE — MEDLINE INDUSTRIES, INC.OMT LLC — OMT, LLCAmericot — AMERICAN SURGICAL COMPANY, LLCCODMAN® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONRay-Cot — AMERICAN SURGICAL COMPANY, LLCMEDLINE INDUSTRIES, INC. — MEDLINE INDUSTRIES, INC.ZEVO™ Anterior Cervical Plate System — MEDTRONIC SOFAMOR DANEK, INC.OMT LLC — OMT, LLCNEURAY ® — MEDTRONIC XOMED, INC.CODMAN® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONNA — MEDTRONIC XOMED, INC.CODMAN® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONCODMAN — Cerenovus, Inc.OMT LLC — OMT, LLCOMT LLC — OMT, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-19 | Medline Industries, LP | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market |
| 2026-03-19 | Medline Industries, LP | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market |
| 2024-09-20 | Integra LifeSciences Corp. | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of- |
| 2024-09-20 | Integra LifeSciences Corp. | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of- |
| 2024-09-20 | Integra LifeSciences Corp. | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of- |
| 2024-09-20 | Integra LifeSciences Corp. | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of- |
| 2024-09-20 | Integra LifeSciences Corp. | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of- |
| 2024-09-20 | Integra LifeSciences Corp. | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of- |
| 2024-09-20 | Integra LifeSciences Corp. | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of- |
| 2024-09-20 | Integra LifeSciences Corp. | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of- |
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