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Integra LifeSciences Corporation

288 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
DuraSeal Dural Sealant System (P040034/S040)Integra LifeSciences Corporation2025-12-17
DuraSeal Exact Spine Sealant System (P080013/S029)Integra LifeSciences Corporation2025-12-17
Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form (P850010/S115)Integra LifeSciences Corporation2025-02-18
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent – Microfibrillar Form (P810006/S111)Integra LifeSciences Corporation2025-02-18
Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form (P850010/S114)Integra LifeSciences Corporation2025-01-14
DuraSeal Dural Sealant System (P040034/S039)Integra LifeSciences Corporation2024-10-30
DuraSeal Exact Spine Sealant System (P080013/S028)Integra LifeSciences Corporation2024-10-30
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent - Microfibrillar Form (P810006/S110)Integra LifeSciences Corporation2024-08-29
Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent - Fibrillar Form (P850010/S113)Integra LifeSciences Corporation2024-08-29
Collastat™ Absorbable Collagen Hemostatic Sponge, Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Form (P810006/S109)Integra LifeSciences Corporation2024-08-22
Helistat® Absorbable Collagen Hemostatic Agent, Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form (P850010/S112)Integra LifeSciences Corporation2024-08-22
Collastat™ Absorbable Collagen Hemostatic Sponge, Collastat™ Absorbable Collagen Hemostatic Agent-Microfibrillar Form (I (P810006/S108)Integra LifeSciences Corporation2024-07-24
Helistat® Absorbable Collagen Hemostatic Agent, Helitene® Absorbable Collagen Hemostatic Agent-Fibrillar Form (P850010/S111)Integra LifeSciences Corporation2024-07-24
Helistat/ Helitene Absorbable Collagen Hemostatic Agent (P850010/S110)Integra LifeSciences Corporation2024-05-22
Collastat/INSTAT Absorbable Collagen Hemostatic Agent (P810006/S107)Integra LifeSciences Corporation2024-05-22
Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form (P850010/S109)Integra LifeSciences Corporation2024-02-21
Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Fo (P810006/S106)Integra LifeSciences Corporation2024-02-21
DuraSeal Exact Spine Sealant System (P080013/S027)Integra LifeSciences Corporation2023-09-05
DuraSeal Dural Sealant System (P040034/S038)Integra LifeSciences Corporation2023-09-05
DuraSeal Exact Spinal Sealant (3mL), DuraSeal Exact Spinal Sealant (5mL) (P080013/S026)Integra LifeSciences Corporation2023-05-24
DuraSeal Dural Sealant System (P040034/S037)Integra LifeSciences Corporation2023-05-24
Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form (P850010/S107)Integra LifeSciences Corporation2023-05-11
Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Fo (P810006/S104)Integra LifeSciences Corporation2023-05-11
Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Fo (P810006/S105)Integra LifeSciences Corporation2023-05-10
Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form (P850010/S108)Integra LifeSciences Corporation2023-05-10
Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form (P850010/S106)Integra LifeSciences Corporation2023-04-18
Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Fo (P810006/S103)Integra LifeSciences Corporation2023-04-18
Collastat/INSTAT Absorbable Collagen Hemostatic Agent (P810006/S102)Integra LifeSciences Corporation2023-02-23
Helistat/Helitene Absorbable Collagen Hemostatic Agent (P850010/S105)Integra LifeSciences Corporation2023-02-23
DuraSeal Exact Spinal Sealant (P080013/S025)Integra LifeSciences Corporation2023-02-16
DuraSeal Dural Sealant System (P040034/S036)Integra LifeSciences Corporation2023-02-16
DuraSeal Dural Sealant System (P040034/S033)Integra LifeSciences Corporation2023-01-25
DuraSeal Exact Spine Sealant System (P080013/S022)Integra LifeSciences Corporation2023-01-25
Helistat® and Helitene® Absorbable Collagen Hemostatic Agents (P850010/S104)Integra LifeSciences Corporation2022-12-19
Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent - Microfibrillar Fo (P810006/S101)Integra LifeSciences Corporation2022-12-19
DuraSeal Dural Sealant System (P040034/S035)Integra LifeSciences Corporation2022-10-07
DuraSeal Exact Spine Sealant System (P080013/S024)Integra LifeSciences Corporation2022-10-07
Helistat® and Helitene® Absorbable Collagen Hemostatic Agents (P850010/S103)Integra LifeSciences Corporation2022-07-06
Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S100)Integra LifeSciences Corporation2022-07-06
Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S099)Integra LifeSciences Corporation2022-05-20
Helistat® and Helitene® Absorbable Collagen Hemostatic Agents (P850010/S102)Integra LifeSciences Corporation2022-05-20
Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Fo (P810006/S098)Integra LifeSciences Corporation2022-04-28
Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form (P850010/S101)Integra LifeSciences Corporation2022-04-28
Helistat and Helitene Absoibable Collagen Hemostatic Agents (P850010/S100)Integra LifeSciences Corporation2022-04-20
DuraSeal Exact Spinal Sealant System. (P080013/S023)Integra LifeSciences Corporation2021-11-17
DuraSeal Dural Sealant System. (P040034/S034)Integra LifeSciences Corporation2021-11-17
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent – Microfibrillar Form (P810006/S096)Integra LifeSciences Corporation2021-11-13
Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S098)Integra LifeSciences Corporation2021-11-13
Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S097)Integra LifeSciences Corporation2021-10-07
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent – Microfibrillar Form (P810006/S095)Integra LifeSciences Corporation2021-09-07
Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent – Fibrillar Form (P850010/S095)Integra LifeSciences Corporation2021-09-07
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S097)Integra LifeSciences Corporation2021-08-12
Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S099)Integra LifeSciences Corporation2021-08-12
Helistaf® and Helitene® Absorbable Collagen Hemostatic Agents (P850010/S096)Integra LifeSciences Corporation2021-04-28
Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S094)Integra LifeSciences Corporation2021-02-26
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S094)Integra LifeSciences Corporation2021-02-26
Helistat® and Helitene® Absorbable Collagen Hemostatic Agents (P850010/S093)Integra LifeSciences Corporation2021-02-04
Collastat™ Absorbable Collagen Hemostatic Sponge and Collaslat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S093)Integra LifeSciences Corporation2021-02-04
Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen hemostatic Agent - Fibrillar Form (P850010/S092)Integra LifeSciences Corporation2021-01-19
Collastat Absorbable Collagen Hemostatic Sponge and Collasta Absorbable Collagen hemostatic Agent - Microfibrillar Form (P810006/S092)Integra LifeSciences Corporation2021-01-19
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S091)Integra LifeSciences Corporation2020-11-18
Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S091)Integra LifeSciences Corporation2020-11-18
DuraSeal Exact Spine Sealant System (P080013/S021)Integra LifeSciences Corporation2020-09-16
DuraSeal Dural Sealant System (P040034/S032)Integra LifeSciences Corporation2020-09-16
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostat Agent - Microfibrillar Form (P810006/S090)Integra LifeSciences Corporation2020-09-04
Helistat Absorbable Collagen Hemostatic Sponge (P850010/S090)Integra LifeSciences Corporation2020-09-04
DuraSeal Exact Spine Sealant System (P080013/S019)Integra LifeSciences Corporation2020-08-17
DuraSeal Dural Sealant System (P040034/S031)Integra LifeSciences Corporation2020-08-17
DuraSeal Exact Spine Sealant System (P080013/S020)Integra LifeSciences Corporation2020-07-22
DuraSeal Exact System (P080013/S018)Integra LifeSciences Corporation2020-04-08
DuraSeal Dural Sealant System (P040034/S030)Integra LifeSciences Corporation2020-04-08
DuraSeal Dural Sealant System (P040034/S029)Integra LifeSciences Corporation2019-07-11
DuraSeal Exact Spine Sealant System (P080013/S017)Integra LifeSciences Corporation2019-07-11
Helistat, Helitene Absorbable Collagen Hemaostatic Agents (P850010/S089)Integra LifeSciences Corporation2019-06-27
Collastat Absorbable Collagen Hemostatic Sponge Collastat Absorbable Collagen Hemostatic-Microfibrillar Form (INSTAT) (P810006/S089)Integra LifeSciences Corporation2019-06-27
Collastat Absorbable Collagen Hemostatic Sponge (P810006/S083)Integra LifeSciences Corporation2019-06-14
Helistat Absorbable Collagen Hemostatic Agent (P850010/S083)Integra LifeSciences Corporation2019-06-14
Collastat Absorbable Collagen Hemostatic Sponge and Collstat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S087)Integra LifeSciences Corporation2019-05-07
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S088)Integra LifeSciences Corporation2019-05-07
Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S087)Integra LifeSciences Corporation2019-05-07
Helistat and Helitene Absorbabale Collagen Hemostatic Agents (P850010/S088)Integra LifeSciences Corporation2019-05-07
Helistat and Helitene Absorbable Collagen Hemostatic Agent (P850010/S086)Integra LifeSciences Corporation2019-04-26
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Hemostatic Agent - Microfibrillar Form (P810006/S086)Integra LifeSciences Corporation2019-04-26
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic- Microfibrillar Form (P810006/S085)Integra LifeSciences Corporation2019-04-19
Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S085)Integra LifeSciences Corporation2019-04-19
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent- Microfibrillar Form (P810006/S084)Integra LifeSciences Corporation2019-03-15
Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent- Fibrillar Form (P850010/S084)Integra LifeSciences Corporation2019-03-15
Helistat Absorbable Collagen Hemostatic Sponge/OraFOAM Absorbable Collagen Hemostatic Sponge (P850010/S082)Integra LifeSciences Corporation2019-03-13
DuraSeal Dural Sealant System (P040034/S028)Integra LifeSciences Corporation2018-11-28
DuraSeal Exact SPine Sealant System (P080013/S016)Integra LifeSciences Corporation2018-11-28
Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent – Microfibrillar Form (P810006/S079)Integra LifeSciences Corporation2018-06-28
Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent – Fibrillar Form (P850010/S078)Integra LifeSciences Corporation2018-06-28
Collastat Absorbable Collagen Hemostatic Sponge, Collastat Absorbable Collagen Hemostatic - Microfibrillar Form (P810006/S082)Integra LifeSciences Corporation2018-05-17
Helistat, Helitene Absorbable Collagen Hemostatic Agents (P850010/S081)Integra LifeSciences Corporation2018-05-17
Hilistat, Helitene, Absorbable Collagen Hemostatic Agents (P850010/S080)Integra LifeSciences Corporation2018-04-25
Collastat, Absorable Collagen, Hemostatic Sponge Collastat, Absorbable Collagen Hemostatic Agent, Microfibrillar Form (P810006/S081)Integra LifeSciences Corporation2018-04-25
DuraSeal Exact Spine Sealant System (P080013/S015)Integra LifeSciences Corporation2018-03-21
DuraSeal Dural Sealant System (P040034/S027)Integra LifeSciences Corporation2018-03-21
Helistat Absorable Collagen Hemostatic Agent and Helitene Absorable Collagen Hemostatic Agent Fibrillar Form (P850010/S079)Integra LifeSciences Corporation2018-02-09
Collastat Absorable Collagen Hemostatic Sponge and Collastat Absorable Collagen Hemostatic Agent Microfibrillar Form (P810006/S080)Integra LifeSciences Corporation2018-02-09
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Every clearance here is in the API, with alerts when new ones post.