| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | Dec 16, 2025 |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug Library | Jul 28, 2025 |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) | Jul 28, 2025 |
| K243529 | Solution Administration Sets | Mar 14, 2025 |
| K242339 | Intravascular Extension Sets and Accessories | Feb 28, 2025 |
| K242390 | Novum IQ Syringe Pump (40800BAXUS) | Sep 5, 2024 |
| K241564 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS | Aug 2, 2024 |
| K230665 | Dose IQ Safety Software | Mar 29, 2024 |
| K211122 | Novum IQ Large Volume Pump | Mar 29, 2024 |
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD… | Mar 12, 2024 |
| K232467 | CleanCart A, CleanCart C, AK 98 Hemodialysis Machine | Sep 14, 2023 |
| K230041 | Spectrum IQ Infusion System with Dose IQ Safety Software | Mar 31, 2023 |
| K230022 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library | Mar 31, 2023 |
| K223175 | lntravascular Administration Sets with Stopcock and Manifold | Mar 10, 2023 |
| K220558 | Blood Administration Sets | Nov 17, 2022 |
| K212262 | PCA Syringe Sets | Oct 3, 2022 |
| K222048 | Spectrum IQ Infusion System with Dose IQ Safety Software | Sep 6, 2022 |
| K211125 | Novum IQ Syringe Pump | Aug 30, 2022 |
| K211124 | Dose IQ Safety Software | Aug 30, 2022 |
| K220417 | Spectrum IQ Infusion System with Dose IQ Safety Software | Apr 29, 2022 |
| K212216 | Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set | Apr 1, 2022 |
| K214016 | 15L Cycler Drainage Bag | Mar 18, 2022 |
| K213639 | Revaclear 500, Revaclear 400, Revaclear 300 | Jan 24, 2022 |
| K211649 | PCEA Syringe Set | Nov 23, 2021 |
| K211035 | U9000 Plus Ultrafilter | Oct 19, 2021 |
| K203609 | Intravascular Administration Sets | Sep 30, 2021 |
| K210430 | Intravascular Extension Set | Jun 18, 2021 |
| K210335 | Blood Administration Set | Jun 10, 2021 |
| K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria… | Nov 19, 2020 |
| DEN190042 | Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer | Aug 28, 2020 |
| K192366 | Intravascular Extension Sets and Accessories | Jul 20, 2020 |
| K201464 | Altapore MIS | Jun 30, 2020 |
| K200640 | ALTAPORE SHAPE | May 8, 2020 |
| K193482 | PrisMax System Version 3 | Mar 13, 2020 |
| K192363 | Altapore | Jan 9, 2020 |
| K192705 | MiniCap Extended Life PD Transfer Sets | Oct 25, 2019 |
| K191513 | Altapore Shape | Oct 19, 2019 |
| K190910 | PrisMax System Version 2 | Jul 25, 2019 |
| K180739 | Clearlink System Solution Set | May 28, 2019 |
| K181225 | ALTAPORE | Aug 31, 2018 |
| K181306 | Actifuse Flow | Aug 17, 2018 |
| K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software | May 11, 2018 |
| K171671 | Prismaflex System 8.10 | Feb 23, 2018 |
| K172544 | IV Fat Emulsion Administration Sets | Sep 22, 2017 |
| K161808 | Solution Set with 1.2 Micron Air Eliminating Filter | Jun 21, 2017 |
| K163530 | PrisMax Control Unit | May 3, 2017 |
| K162887 | PrismaSATE | Jan 6, 2017 |
| K160007 | Paclitaxel Sets | Dec 19, 2016 |
| K161323 | Solution Set for Epidural Use | Nov 30, 2016 |
| K153158 | Solution Administration Sets with 0.2 Micron Filter | Dec 28, 2015 |
| K152675 | EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR… | Oct 29, 2015 |
| K152129 | FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution | Oct 29, 2015 |
| K150860 | Nitroglycerin Sets with DUO-VENT Spike | Apr 16, 2015 |
| K142600 | VIAL-MATE Adaptor | Nov 19, 2014 |
| K142011 | SOLUTION SET/EXTENSION SET | Aug 18, 2014 |
| K133801 | BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY | May 7, 2014 |
| K130531 | ULTRAFUSE | Apr 8, 2014 |
| K132734 | NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS | Oct 8, 2013 |
| K130245 | LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE… | Mar 1, 2013 |
| K123874 | INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED… | Jan 10, 2013 |
| K123868 | INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS… | Jan 8, 2013 |
| K121634 | INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH… | Jun 29, 2012 |
| K121092 | FLOWEASE [SUBCUTANEOUS] INFUSION SET | Jun 29, 2012 |
| K113227 | NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER | Dec 8, 2011 |
| K112893 | CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS | Oct 18, 2011 |
| K111217 | ADDITIVE CAP | Jun 14, 2011 |
| K102936 | HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310… | Mar 30, 2011 |
| K103551 | INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER… | Mar 25, 2011 |
| K103245 | CELSTAT | Mar 23, 2011 |
| K101385 | DUAL LUER LOCK CAP, MODEL 2C6250 | Jun 22, 2010 |
| K092318 | BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE | Oct 30, 2009 |
| K090002 | ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A | Aug 7, 2009 |
| K083778 | XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210 | Feb 20, 2009 |
| K090096 | ALL-IN-ONE CONTAINER | Jan 30, 2009 |
| K081717 | TRICOS A RESORBABLE BONE SUBSTITUTE | Oct 10, 2008 |
| K081721 | TRICOS A RESORBABLE SUBSTITUTE | Aug 6, 2008 |
| K081289 | V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER… | Aug 4, 2008 |
| K073571 | TRICOS T RESORBABLE BONE SUBSTITUTE | Apr 8, 2008 |
| K072576 | CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK… | Nov 6, 2007 |
| K071222 | INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES | May 25, 2007 |
| K070125 | COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION | Apr 16, 2007 |
| K052973 | IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K | Jan 25, 2007 |
| K062079 | XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 | Oct 19, 2006 |
| K062457 | INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES | Sep 21, 2006 |
| K061515 | RENALSOFT | Sep 11, 2006 |
| K053539 | MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 | May 24, 2006 |
| K060074 | INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326 | Mar 29, 2006 |
| K053512 | HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310 | Feb 16, 2006 |
| K051722 | TRICOS T | Nov 18, 2005 |
| K051370 | STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 | Aug 12, 2005 |
| K051253 | MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT… | Jul 15, 2005 |
| K040985 | PUMP CONNECTIVITY INTERFACE | Nov 30, 2004 |
| K042936 | SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE | Nov 26, 2004 |
| K042410 | BAXJECT II | Oct 8, 2004 |
| K041428 | ACCUSOL DIALYSIS SOLUTION | Aug 27, 2004 |
| K041738 | BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME) | Jul 9, 2004 |
| K041191 | COLLEAGUE VOLUMETRIC INFUSION PUMPS | Jun 25, 2004 |
| K031676 | HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q | Nov 20, 2003 |
| K031882 | ENDOSCOPIC APPLICATOR | Sep 5, 2003 |
| K031566 | SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 | Aug 19, 2003 |