Company
Integra Limited
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HWC | Screw, Fixation, Bone | 3 |
| FWZ | Operating Room Accessories Table Tray | 2 |
| GWM | Device, Monitoring, Intracranial Pressure | 1 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 1 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 1 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 1 |
| LFL | Instrument, Ultrasonic Surgical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2019 | Integra Limited Integra Flowable Wound Matrix
Catalog No: FWD301
Product Usage:
Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor si Terminated |
KGN | K072113 |
| Mar 1, 2019 | Integra Limited Integra bioBLOCK Resorbable subtaler Implant, 12mm
Catalog Number: 040012 - Product Usage:
The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of Terminated |
HWC | K051611 |
| Mar 1, 2019 | Integra Limited Integra bioBLOCK Resorbable subtaler Implant, 11mm
Catalog Number: 040011 - Product Usage:
The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of Terminated |
HWC | K051611 |
| Mar 1, 2019 | Integra Limited Integra bioBLOCK Resorbable subtaler Implant, 10mm
Catalog Number: 40010 - Product Usage:
The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of Terminated |
HWC | K051611 |
| Oct 30, 2013 | Integra Limited Brand Names: Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring
Catheters.
Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC.
The fully packaged 110-4B, 110- Terminated |
GWM | K102875 |
| Aug 26, 2013 | Integra Limited Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware.
The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining re Terminated |
HBG | K902818 |
| Sep 26, 2012 | Integra Limited The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base Units and MAYFIELD Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial st Terminated |
FWZ | None listed |
| Sep 26, 2012 | Integra Limited The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base Units and MAYFIELD Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial st Terminated |
FWZ | None listed |
| Jul 18, 2012 | Integra Limited Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments.
Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedure Terminated |
KNF | K103726 |
| Jun 17, 2011 | Integra Limited Integra CUSA NXT Ultrasonic Tissue Ablation System Service Module
The CUSA NXT Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation. emulsification and Terminated |
LFL | K081459 |