Data / Medical devices / United States / Natus Medical Incorporated
Natus Medical Incorporated: FDA-registered device maker in San Diego, CA, United States, 31 510(k) clearances
Natus Medical Incorporated is registered with the FDA (registration 2023988) in San Diego, CA, United States. It lists 7 device types. The FDA files 31 510(k) clearances under its listings, the newest dated October 28, 2016. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2023988
- Address
- 6225 Nancy Ridge Dr, San Diego, CA, United States, 92121
- Owner or operator
- Natus Medical Incorporated (9004873)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- October 30, 2017
- Registered through
- 2026
- Brand names listed
- 025420 PMIO Patient Bedside Monitor Cable, 025430 AC Power Adapter, 025440 USB-to-RS232 Adapter Cable, 026950 14.4V Li-ion Battery, CAM02 Camino ICP Monitor, CAMCABL Camino Fiber Optic Catheter Cable, Camino Flex Ventricular Intracranial Pressure Monitoring Kit, Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, model 110-4L and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Monitoring, Intracranial Pressure | GWM | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Drills, Burrs, Trephines & Accessories (Manual) | HBG | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Shunt System Implantation | GYK | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Intracranial Pressure & Temperature Monitoring Kit | PSP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Port & Catheter, Implanted, Subcutaneous, Intraventricular | LKG | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Shunt, Central Nervous System And Components | JXG | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stainless Steel Instrument, Shunt System Implantation | PIY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 28, 2016 | K162437 | Codman EDS3 CSF External Drainage System | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| September 22, 2016 | K161992 | Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| March 14, 2016 | K153041 | Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| March 4, 2016 | K152897 | Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| March 6, 2014 | K133754 | INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER | GWM | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| September 10, 2012 | K121573 | INTEGRA CAMINO ICP MONITOR | GWM | Substantially Equivalent | Intrgra Lifesciences Corporation | accessdata.fda.gov |
| July 20, 2012 | K121159 | INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER | GWM | Substantially Equivalent | Integra Lifescience Corportation | accessdata.fda.gov |
| July 7, 2011 | K101381 | HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| December 20, 2010 | K102875 | CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C | GWM | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| September 29, 2006 | K061568 | CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| December 17, 2003 | K033698 | CONTOUR-FLEX VALVE AND SHUNT SYSTEM | JXG | Substantially Equivalent | Integra Neurosciences Implants S.A. | accessdata.fda.gov |
| November 12, 2002 | K022712 | HAND DRILL, MODEL 11-9901-7 | HBG | Substantially Equivalent | Medical Design, LLC | accessdata.fda.gov |
| February 6, 1998 | K971799 | PRECISION FLOW OSV II | JXG | Substantially Equivalent | Elekta Implants, SA | accessdata.fda.gov |
| June 25, 1997 | K964923 | CODMAN LUMBAR DRAINAGE CATHETER KIT | JXG | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| December 20, 1996 | K962928 | COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/) | GWM | Substantially Equivalent | Camino Neurocare, Inc. | accessdata.fda.gov |
| October 25, 1996 | K960159 | CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS) | JXG | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| March 25, 1996 | K955832 | CORDIS VENTRICULAR ANTECHAMBER (VA) | JXG | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| October 24, 1995 | K954021 | EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II) | JXG | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| October 19, 1995 | K944595 | CORDIS HORIZONTAL-VERICAL VALVE SYSTEM | JXG | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| May 9, 1995 | K950315 | CORDIS CSF RESERVOIR | LKG | Unknown | Cordis Corp. | accessdata.fda.gov |
| March 2, 1994 | K925810 | CORDIS POLYPROPYLENE BURR HOLE RESERVOIR | JXG | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| August 23, 1993 | K932273 | CORDIS TUNNELER | GYK | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| October 30, 1992 | K921936 | CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR | JXG | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| January 17, 1992 | K914735 | VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM | GWM | Substantially Equivalent | Camino Laboratories, Inc. | accessdata.fda.gov |
| September 16, 1991 | K911433 | RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE | JXG | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| August 16, 1991 | K910938 | CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II) | JXG | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| October 31, 1989 | K895868 | HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE | GYK | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| June 19, 1986 | K861377 | STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES | JXG | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
| June 26, 1981 | K811288 | SPETZLER LUMBAR-PERITONEAL SYSTEM | JXG | Substantially Equivalent | American Heyer Schulte | accessdata.fda.gov |
| December 18, 1980 | K802586 | AMERICAN HEYER-SCHULTE LOW PROFILE VALVE | JXG | Substantially Equivalent | American Heyer Schulte | accessdata.fda.gov |
| August 16, 1977 | K771529 | PERITONEAL INTRODUCER & SHEATH | GYK | Substantially Equivalent | Cordis Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 28, 2023 | 93550 | Class II | Ongoing | External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only | Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. | accessdata.fda.gov |
| November 18, 2022 | 91193 | Class II | Ongoing | The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intracranial burr-hole typically required for procedures such as ventriculo | Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable. | accessdata.fda.gov |
| March 16, 2009 | 51674 | Not yet classified | Terminated | Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit NL950-V and Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit with Ventricular Drainage System NL950-VC. This intracra | Due to a dimensional error, the diameter of the stylet provided with the device may be too large to insert into the lumen of the catheter tip. | accessdata.fda.gov |
| January 28, 2008 | 46788 | Not yet classified | Terminated | INTEGRA NeuroSensor Probe, REF NS-P, component of Cerebral Blood Flow and Intracranial Pressure Monitoring Kit, Integra NeuroSciences | Incorrect pressure reading: Due to a manufacturing error, the ICP reading could be inaccurate to the extent that they exceed label claims. Specifically, the Insertion Error label claim of +/- 3mmHg could be exceeded by up to -3mmHg, that could result in a maximum Insertion Error of +/- 6mmHg. | accessdata.fda.gov |
| September 8, 2005 | 33451 | Not yet classified | Terminated | NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit | Certain Model NS-P probes contained in the NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit may allow an Intracranial Pressure (ICP) drift of up to 5 mmHg during the first 24 hours of monitoring ICP. This is outside the products labeling specification of 2 mmHg maximum ICP drift within the first 24 hours of monitoring. | accessdata.fda.gov |
| January 21, 2005 | 31117 | Not yet classified | Terminated | LICOX Complete Brain IMC Probe Kit, Model IM3.ST C | LICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever. | accessdata.fda.gov |
Compare with other makers
- All makers of Shunt, Central Nervous System And Components
- All makers of Device, Monitoring, Intracranial Pressure
- All makers of Instrument, Shunt System Implantation
- All makers of Port & Catheter, Implanted, Subcutaneous, Intraventricular
- All makers of Intracranial Pressure & Temperature Monitoring Kit
- All makers of Stainless Steel Instrument, Shunt System Implantation
Updated January 4, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.