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Integra LifeSciences Corp.

180 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, an recall (Z-1295-2025)Integra LifeSciences Corp.2025-03-06
Brand Name: MediHoney Gel Product Name: MediHoney Wound & Burn Dressing Gel Model/Catalog recall (Z-1168-2025)Integra LifeSciences Corp.2025-02-12
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implan recall (Z-0977-2025)Integra LifeSciences Corp.2025-01-17
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Imp recall (Z-0978-2025)Integra LifeSciences Corp.2025-01-17
CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implan recall (Z-0979-2025)Integra LifeSciences Corp.2025-01-17
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694 recall (Z-0262-2025)Integra LifeSciences Corp.2024-10-30
MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical S recall (Z-0235-2025)Integra LifeSciences Corp.2024-10-29
SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical st recall (Z-0236-2025)Integra LifeSciences Corp.2024-10-29
SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips recall (Z-0237-2025)Integra LifeSciences Corp.2024-10-29
SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical stri recall (Z-0238-2025)Integra LifeSciences Corp.2024-10-29
SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical stri recall (Z-0239-2025)Integra LifeSciences Corp.2024-10-29
SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical stri recall (Z-0240-2025)Integra LifeSciences Corp.2024-10-29
SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips recall (Z-0241-2025)Integra LifeSciences Corp.2024-10-29
SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and surgical strips a recall (Z-0242-2025)Integra LifeSciences Corp.2024-10-29
SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical st recall (Z-0243-2025)Integra LifeSciences Corp.2024-10-29
SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips recall (Z-0244-2025)Integra LifeSciences Corp.2024-10-29
SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical strips recall (Z-0245-2025)Integra LifeSciences Corp.2024-10-29
SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips a recall (Z-0246-2025)Integra LifeSciences Corp.2024-10-29
SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips a recall (Z-0247-2025)Integra LifeSciences Corp.2024-10-29
SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgical strips are recall (Z-0248-2025)Integra LifeSciences Corp.2024-10-29
SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surgical strips are recall (Z-0249-2025)Integra LifeSciences Corp.2024-10-29
SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are recall (Z-0250-2025)Integra LifeSciences Corp.2024-10-29
SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are recall (Z-0251-2025)Integra LifeSciences Corp.2024-10-29
SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips a recall (Z-0252-2025)Integra LifeSciences Corp.2024-10-29
SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and surgical strips a recall (Z-0253-2025)Integra LifeSciences Corp.2024-10-29
SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are i recall (Z-0254-2025)Integra LifeSciences Corp.2024-10-29
SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are i recall (Z-0255-2025)Integra LifeSciences Corp.2024-10-29
SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips ar recall (Z-0256-2025)Integra LifeSciences Corp.2024-10-29
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1. recall (Z-0054-2025)Integra LifeSciences Corp.2024-10-10
TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instrumen recall (Z-2507-2024)Integra LifeSciences Corp.2024-08-05
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, an recall (Z-2331-2024)Integra LifeSciences Corp.2024-07-11
CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where f recall (Z-2167-2024)Integra LifeSciences Corp.2024-06-21
CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the recall (Z-2136-2024)Integra LifeSciences Corp.2024-06-12
CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricl recall (Z-2137-2024)Integra LifeSciences Corp.2024-06-12
CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access recall (Z-2138-2024)Integra LifeSciences Corp.2024-06-12
Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventricul recall (Z-1873-2024)Integra LifeSciences Corp.2024-05-20
Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarach recall (Z-1193-2024)Integra LifeSciences Corp.2024-02-28
Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the recall (Z-1194-2024)Integra LifeSciences Corp.2024-02-28
Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the recall (Z-1195-2024)Integra LifeSciences Corp.2024-02-28
Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For a recall (Z-1196-2024)Integra LifeSciences Corp.2024-02-28
Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the recall (Z-1197-2024)Integra LifeSciences Corp.2024-02-28
Ref No: INS7260 / Integra Cranial Access Kit. For access to the subarachnoid space or the recall (Z-1198-2024)Integra LifeSciences Corp.2024-02-28
Ref No: INS7270 / Integra Cranial Access Kit. For access to the subarachnoid space or the recall (Z-1199-2024)Integra LifeSciences Corp.2024-02-28
INS7280 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral recall (Z-1200-2024)Integra LifeSciences Corp.2024-02-28
Ref No: INSHITH / Integra Cranial Access Kit. For access to the subarachnoid space or the recall (Z-1201-2024)Integra LifeSciences Corp.2024-02-28
Ref No: INSHITHND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For recall (Z-1202-2024)Integra LifeSciences Corp.2024-02-28
Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or t recall (Z-1203-2024)Integra LifeSciences Corp.2024-02-28
CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink recall (Z-0548-2024)Integra LifeSciences Corp.2023-12-14
Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subara recall (Z-0491-2024)Integra LifeSciences Corp.2023-12-06
Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles recall (Z-0492-2024)Integra LifeSciences Corp.2023-12-06
Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricle recall (Z-0493-2024)Integra LifeSciences Corp.2023-12-06
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles recall (Z-0494-2024)Integra LifeSciences Corp.2023-12-06
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles recall (Z-0495-2024)Integra LifeSciences Corp.2023-12-06
Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles recall (Z-0496-2024)Integra LifeSciences Corp.2023-12-06
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles recall (Z-0497-2024)Integra LifeSciences Corp.2023-12-06
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles recall (Z-0498-2024)Integra LifeSciences Corp.2023-12-06
Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or th recall (Z-0499-2024)Integra LifeSciences Corp.2023-12-06
Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an int recall (Z-1614-2023)Integra LifeSciences Corp.2023-05-19
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457 recall (Z-0909-2023)Integra LifeSciences Corp.2023-01-06
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor. recall (Z-1395-2022)Integra LifeSciences Corp.2022-07-22
CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, wi recall (Z-1354-2021)Integra LifeSciences Corp.2021-04-05
13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a recall (Z-2953-2020)Integra LifeSciences Corp.2020-09-12
Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin recall (Z-2954-2020)Integra LifeSciences Corp.2020-09-12
Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cuttin recall (Z-2955-2020)Integra LifeSciences Corp.2020-09-12
MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-1 recall (Z-1310-2019)Integra LifeSciences Corp.2019-05-20
MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: T recall (Z-1311-2019)Integra LifeSciences Corp.2019-05-20
LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020S recall (Z-1312-2019)Integra LifeSciences Corp.2019-05-20
The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the recall (Z-1463-2018)Integra LifeSciences Corp.2018-04-20
Integra Cadence Total Ankle System recall (Z-1192-2017)Integra LifeSciences Corp.2017-02-11
Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments recall (Z-1866-2016)Integra LifeSciences Corp.2016-05-31
Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments recall (Z-1867-2016)Integra LifeSciences Corp.2016-05-31
Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact H recall (Z-0025-2016)Integra LifeSciences Corp.2015-10-06
Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Cata recall (Z-1815-2015)Integra LifeSciences Corp.2015-06-18
The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Tempera recall (Z-1618-2015)Integra LifeSciences Corp.2015-05-15
The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Tempera recall (Z-1619-2015)Integra LifeSciences Corp.2015-05-15
The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Tempera recall (Z-1620-2015)Integra LifeSciences Corp.2015-05-15
Integra Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model recall (Z-1452-2015)Integra LifeSciences Corp.2015-04-16
Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring recall (Z-0831-2015)Integra LifeSciences Corp.2014-12-18
Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint betwe recall (Z-0813-2015)Integra LifeSciences Corp.2014-12-16
Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory us recall (Z-0491-2015)Integra LifeSciences Corp.2014-12-01
Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, recall (Z-0201-2015)Integra LifeSciences Corp.2014-11-10
Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees recall (Z-0197-2015)Integra LifeSciences Corp.2014-11-08
Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP recall (Z-2182-2014)Integra LifeSciences Corp.2014-08-11
Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, recall (Z-2072-2014)Integra LifeSciences Corp.2014-07-17
Integra LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Ba recall (Z-1976-2014)Integra LifeSciences Corp.2014-07-02
MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm); 60 recall (Z-1961-2014)Integra LifeSciences Corp.2014-07-01
Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 1321 recall (Z-1868-2014)Integra LifeSciences Corp.2014-06-25
Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and recall (Z-1675-2014)Integra LifeSciences Corp.2014-05-30
Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz recall (Z-1522-2014)Integra LifeSciences Corp.2014-04-29
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA Excel System Product Usage: Intended for recall (Z-0994-2014)Integra LifeSciences Corp.2014-02-20
Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver recall (Z-0938-2014)Integra LifeSciences Corp.2014-02-07
Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSc recall (Z-0621-2014)Integra LifeSciences Corp.2014-01-03
Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSc recall (Z-0622-2014)Integra LifeSciences Corp.2014-01-03
Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 3 recall (Z-0602-2014)Integra LifeSciences Corp.2013-12-27
Composite Series Skull Clamp, one clamp per tote. The MAYFIELD Skull Clamp (A3059) is a cr recall (Z-0210-2014)Integra LifeSciences Corp.2013-11-13
Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx On recall (Z-0054-2014)Integra LifeSciences Corp.2013-10-23
Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; Rx On recall (Z-0055-2014)Integra LifeSciences Corp.2013-10-23
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Onl recall (Z-0056-2014)Integra LifeSciences Corp.2013-10-23
Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 recall (Z-0057-2014)Integra LifeSciences Corp.2013-10-23
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx On recall (Z-0058-2014)Integra LifeSciences Corp.2013-10-23
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