| Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) (K261004) | Integra Lifesciences Production Corporation | 2026-06-23 |
| Intellidrop (K251598) | Brainspace, Inc. | 2025-12-10 |
| Sophy Mini Monopressure Valve (SM1) (K250636) | Sophysa | 2025-11-28 |
| EVAC-MRI (K252514) | Phasor Health, LLC | 2025-11-05 |
| Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (K243531) | Integra Lifesciences Production Corporation | 2025-08-08 |
| Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762) (K243552) | Integra Lifesciences Production Corporation | 2025-08-06 |
| External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters (K242974) | Sophysa | 2025-06-20 |
| EVAC (K243205) | Phasor Health, LLC | 2025-06-03 |
| Duet External Drainage and Monitoring System (EDMS) (K243676) | Medtronic Neurosurgery | 2025-03-10 |
| XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (K242003) | Aesculap, Inc. | 2024-12-16 |
| Borvo EVAC System (Ergo); Borvo EVAC System (Classic) (K241458) | Borvo Medical, Inc. | 2024-08-20 |
| Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter (K233445) | Integra Lifesciences Production Corporation | 2024-01-17 |
| Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set (K233448) | Integra Lifesciences Production Corporation | 2023-12-19 |
| IRRAflow Active Fluid Exchange System (AFES) (K231664) | Irras USA, Inc. | 2023-10-19 |
| External Drainage System (K221694) | Jmed(Shenzhen) Technology Limited | 2023-02-09 |
| Polaris Valve Electronic Reading Instrument (K222422) | Sophysa | 2023-02-02 |
| Certas Plus Programmable Valves (K223330) | Integra Lifesciences Production Corporation | 2023-02-01 |
| Reflow System Mini and ReFlow Mini Flusher (K223603) | Anuncia Medical, Inc. | 2022-12-29 |
| IRRAflow Active Fluid Exchange System (AFES) (K222471) | Irras USA | 2022-12-08 |
| Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves (K221840) | Integra Lifesciences Production Corporation | 2022-10-14 |
| ReFlow System Mini (K221918) | Anuncia Medical, Inc. | 2022-09-29 |
| StrataMR II Valves and Shunts (K212641) | Medtronic Neurosurgery | 2021-09-16 |
| Ventricular Catheter (K200950) | Aesculap, Inc. | 2020-05-08 |
| IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (K200807) | Irras USA, Inc. | 2020-04-29 |
| M. Blue Adjustable Shunt System (K192266) | Aesculap, Inc. | 2019-11-21 |
| IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (K192289) | Irras USA, Ltd. | 2019-11-15 |
| MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System (K191684) | Integra LifeSciences Corporation | 2019-10-11 |
| Miethke Shunt System GAV 2.0 and SA 2.0 Valves (K190174) | Aesculap, Inc. | 2019-07-05 |
| CodMan Certas Plus Programmable Valve (K182265) | Integra Lifesciences Corp. | 2018-11-20 |
| Codman Certas Plus Electronic Tool Kit (K181902) | Integra Lifesciences Corp. | 2018-10-25 |
| StrataMR guider tool (K181622) | Medtronic Neurosurgery | 2018-10-01 |
| IRRAflow CNS System (K171880) | Irras, Inc. | 2018-07-13 |
| Smart External Drain (SED) System (K181301) | Aqueduct Critical Care, Inc. | 2018-06-14 |
| EKOS ultrasound EVD Device, EVD Control Unit (K172035) | Btg International, Inc. | 2018-03-24 |
| Smart External Drain (SED) System (K172759) | Aqueduct Critical Care, Inc. | 2017-11-14 |
| Alivio Ventricular Catheter and Flusher System (Alivio System) (K172006) | Alcyone Lifesciences, Inc. | 2017-11-09 |
| Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag (K172537) | Codman & Shurtleff, Inc. | 2017-10-16 |
| CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) (K172022) | Codman & Shurtleff, Inc. | 2017-10-03 |
| SureFlo EVD Catheter (K170599) | Arkis Biosciences, Inc. | 2017-08-31 |
| Smart External Drain (SED) System (K171586) | Aqueduct Critical Care, Inc. | 2017-06-30 |
| proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System (K161853) | Aesculap, Inc. | 2017-02-27 |
| Codman EDS3 CSF External Drainage System (K162437) | Codman & Shurtleff, Inc. | 2016-10-28 |
| Smart External Drain (SED) System (K161605) | Aqueduct Critical Care, Inc. | 2016-10-27 |
| Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems (K161992) | Integra LifeSciences Corporation | 2016-09-22 |
| StrataMR Valves and Shunts (K152700) | Medtronic Neurosurgery | 2016-04-07 |
| Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling (K153041) | Integra LifeSciences Corporation | 2016-03-14 |
| Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory (K152897) | Integra LifeSciences Corporation | 2016-03-04 |
| LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm (K150898) | Moller Medical GmbH | 2015-12-18 |
| Codman Certas Plus Programmable Valve (K152152) | Medos International SARL | 2015-10-27 |
| AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM (K141687) | Aesculap, Inc. | 2015-04-02 |
| POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX (K141227) | Sophysa SA | 2015-04-02 |
| Codman Certas Plus Programmable Valve; Codman Certas Toll Kit (K143111) | Medos International SARL | 2015-02-19 |
| INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS (K140722) | Integra LifeSciences Corporation | 2015-01-06 |
| LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC (K121248) | Moller Medical GmbH | 2013-12-13 |
| SHUNTCHECK (K123554) | Neurodx Development, LLC | 2013-03-07 |
| MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM (K123524) | Medtronic Neurosurgery | 2013-02-13 |
| HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM (K122118) | Codman & Shurtleff, Inc. | 2012-08-03 |
| AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM (K120559) | Aesculap, Inc. | 2012-05-24 |
| CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM (K113526) | Medos International SARL | 2012-02-16 |
| MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER (K110560) | Medtronic Neurosurgery | 2011-11-18 |
| AESCULAP- MEITHKE SHUNT SYSTEM (K110206) | Aesculap, Inc. | 2011-10-27 |
| CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM (K112156) | Medos International SARL | 2011-10-17 |
| HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS (K101381) | Integra LifeSciences Corporation | 2011-07-07 |
| CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER (K110751) | Codman & Shurtleff, Inc. | 2011-05-09 |
| HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM (K102961) | Codman & Shurtleff, Inc. | 2011-02-18 |
| CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER (K102589) | Codman & Shurtleff, Inc. | 2011-01-14 |
| AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM (K103003) | Aesculap, Inc. | 2010-11-09 |
| OSV II LOW FLOW LOW PRO VALVE (K093968) | Integra LifeSciences Corporation | 2010-01-22 |
| SIPHONX GRAVITATIONAL ANTISIPHON DEVICE (K091328) | Sophysa SA | 2010-01-22 |
| OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM (K092395) | Integra Lifesciences Corp. | 2009-11-19 |
| PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM (K091312) | Medtronic Neurosurgery | 2009-09-02 |
| POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400 (K090342) | Sophysa SA | 2009-08-11 |
| CODMAN HAKIM MICRO II VALVE (K091346) | Codman & Shurtleff, Inc. | 2009-06-02 |
| CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET (K090348) | Codman & Shurtleff, Inc. | 2009-03-04 |
| STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 (K083076) | Medtronic Neurosurgery | 2008-11-20 |
| OSV II (K081773) | Integra Neurosciences Implants S.A. | 2008-11-06 |
| STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635 (K082127) | Medtronic Neurosurgery | 2008-08-27 |
| NEUROCATH AG (K081942) | Vygon Neuro | 2008-08-12 |
| SHUNTCHECK - CSF SHUNT FLOW DETECTOR (K080168) | Neuro Diagnostic Devices | 2008-05-16 |
| SMALL LUMEN PERITONEAL CATHETER (K073139) | Medtronic Neurosurgery | 2008-01-30 |
| LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030 (K072929) | Integra LifeSciences Corporation | 2007-12-07 |
| RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715 (K063836) | Medtronic Neurosurgery | 2007-08-16 |
| AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T (K062009) | Aesculap, Inc. | 2007-01-17 |
| CODMAN VPV SYSTEM, MODEL 82-3192 (K061876) | Codman & Shurtleff, Inc. | 2006-10-16 |
| CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 (K061568) | Codman & Shurtleff, Inc. | 2006-09-29 |
| MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS (K062599) | Integra LifeSciences Corporation | 2006-09-27 |
| MEDTRONIC PS MEDICAL STRATA TYPE VALUE (K060681) | Medtronic Neurosurgery | 2006-09-15 |
| CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD (K053107) | Codman & Shurtleff, Inc. | 2006-01-19 |
| MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS (K053350) | Codman & Shurtleff, Inc. | 2006-01-19 |
| MEDTRONIC M2 MAGNET ADJUSTMENT TOOL (K052386) | Medtronic Neurosurgery | 2005-12-16 |
| CODMAN VPV SYSTEM, MODEL 82-3192 (K050739) | Codman & Shurtleff, Inc. | 2005-07-18 |
| MEDTRONIC STRATAVARIUS (K041992) | Medtronic Neurosurgery | 2005-01-28 |
| ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM (K042825) | Integra LifeSciences Corporation | 2004-12-21 |
| POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 (K042481) | Sophysa SA | 2004-12-14 |
| SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL (K042359) | Medical Designs, LLC | 2004-11-17 |
| SHUNTCHECK (PROMETHEUS 1) (K040021) | Samuel Neff M.D. | 2004-11-02 |
| PS MEDICAL STRATA II VALVE (K042465) | Medtronic Neurosurgery | 2004-10-19 |
| EQUI-FLOW VALVE AND SHUNT SYSTEM (K042558) | Integra Neurosciences Implants S.A. | 2004-10-06 |
| PS MEDICAL NEUROSURGICAL IMPLANTS (K042198) | Medtronic Neurosurgery | 2004-09-24 |
| LOW FLOW OSV II HYDROCEPHALUS VALVE (K042192) | Integra Neurosciences Implants S.A. | 2004-09-02 |