Medical device manufacturer
Integra LifeSciences Corporation
Integra LifeSciences Corporation holds 94 FDA 510(k) clearances across 29 product codes. Median elapsed review time is 80 days. openFDA lists 338 recall records naming the company. FDA publishes it under 12 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 94
- Product codes
- 29
- Median review
- 80 days
- Recall records
- 338
How does FDA spell Integra LifeSciences Corporation?
FDA publishes this company under 12 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| INTEGRA LIFESCIENCES CORPORATION | device/registrationlisting | normalised |
| Integra LifeSciences Corp | device/enforcement | normalised |
| Integra LifeSciences Corp | device/recall | normalised |
| Integra LifeSciences Corp. | device/enforcement | normalised |
| Integra LifeSciences Corp. | device/recall | normalised |
| Integra LifeSciences Corp. d.b.a. Integra Pain Management | device/recall | normalised |
| Integra LifeSciences Corp. d.b.a. Integra Pain Management | device/enforcement | normalised |
| Integra LifeSciences Corporation | device/enforcement | normalised |
Showing 8 of 12.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Integra LifeSciences Corporation file in?
29 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | 14 | 91 days | |
| LFL | Instrument, Ultrasonic Surgical | 13 | 95 days | |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 10 | 54 days | |
| GWM | Device, Monitoring, Intracranial Pressure | 8 | 78 days | |
| KGN | Wound Dressing With Animal-Derived Material(S) | 7 | 79 days | |
| GXQ | Dura Substitute | 6 | 28 days | |
| HRS | Plate, Fixation, Bone | 5 | 76 days | |
| JXI | Cuff, Nerve | 4 | 30 days | |
| PHX | Shoulder Prosthesis, Reverse Configuration | 4 | 120 days | |
| MQV | Filler, Bone Void, Calcium Compound | 3 | 131 days | |
| HAE | Rongeur, Manual | 2 | 56 days | |
| DQR | Cannula, Catheter | 1 | 161 days | |
| EJI | Syringe, Cartridge | 1 | 63 days | |
| FSR | Light, Headband, Surgical | 1 | 76 days | |
| FTM | Mesh, Surgical | 1 | 35 days | |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 252 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 56 days | |
| GWG | Endoscope, Neurological | 1 | 28 days | |
| GYC | Electrode, Cortical | 1 | 57 days | |
| HAW | Neurological Stereotaxic Instrument | 1 | 257 days | |
| HBA | Neurosurgical Paddie | 1 | 353 days | |
| HBF | Drills, Burrs, Trephines & Accessories (Compound, Powered) | 1 | 30 days | |
| HCZ | Forceps, Surgical, Gynecological | 1 | 101 days | |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 134 days | |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 1 | 24 days |
Showing the 25 they file in most, of 29.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Integra LifeSciences Corporation had a recall?
openFDA lists 338 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1295-2025Class IIOpen, ClassifiedGWG
Possibility for the obturator to break (separate).
Z-1168-2025Class IIOpen, ClassifiedFRO
Potential that the induction seal is not completely sealed to the device tube packaging.
Z-0977-2025Class IIOpen, ClassifiedJXG
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Z-0978-2025Class IIOpen, ClassifiedJXG
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Z-0979-2025Class IIOpen, ClassifiedJXG
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Showing the 5 most recently initiated of 338.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Integra LifeSciences Corporation cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator System | LFL | 176 | |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | GWG | 28 | |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator System | LFL | 142 | |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | 144 | |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | 60 | |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | 28 | |
| K210128 | INTEGRA Wound Matrix (Macro-Channels) | KGN | 262 | |
| K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System | HRS | 204 | |
| K193346 | Codman Surgical Patties & Strips | HBA | 353 | |
| K201507 | Cadence Total Ankle System | HSN | 24 |
Source: openFDA device/510k · retrieved
Where is Integra LifeSciences Corporation registered?
FDA lists 3 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Integra LifeSciences Corporation files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.