| Z-2126-2014 | Class II | FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the… | Jul 11, 2014 |
| D-1593-2014 | Class I | Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only… | Jul 11, 2014 |
| D-1592-2014 | Class I | 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container… | Jul 11, 2014 |
| D-1591-2014 | Class I | 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41… | Jul 11, 2014 |
| Z-2074-2014 | Class II | Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. | Jun 17, 2014 |
| D-1413-2014 | Class II | Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL)… | Jun 16, 2014 |
| Z-1963-2014 | Class II | EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display… | Jun 10, 2014 |
| D-1550-2014 | Class I | 0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare… | May 12, 2014 |
| Z-2246-2017 | Class II | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile… | Apr 28, 2014 |
| Z-0932-2015 | Class II | Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to… | Apr 24, 2014 |
| D-0293-2015 | Class II | Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile… | Apr 24, 2014 |
| D-1282-2014 | Class II | 0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare… | Apr 21, 2014 |
| Z-1536-2015 | Class II | The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device… | Apr 17, 2014 |
| Z-1245-2015 | Class II | AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult… | Apr 3, 2014 |
| D-1276-2014 | Class I | Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx… | Feb 11, 2014 |
| Z-1484-2014 | Class I | SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum… | Feb 7, 2014 |
| D-1163-2014 | Class I | 0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers… | Nov 21, 2013 |
| D-1162-2014 | Class I | 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter… | Nov 21, 2013 |
| D-1160-2014 | Class I | Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber… | Nov 18, 2013 |
| D-1159-2014 | Class I | Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium)… | Nov 18, 2013 |
| D-1158-2014 | Class I | Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual… | Nov 18, 2013 |
| D-1057-2014 | Class I | 50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter… | Nov 18, 2013 |
| D-368-2014 | Class II | 10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Infusion, Baxter… | Nov 12, 2013 |
| Z-0607-2014 | Class II | IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to… | Nov 8, 2013 |
| Z-0080-2015 | Class II | 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal… | Oct 17, 2013 |
| Z-1292-2015 | Class II | The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated… | Oct 16, 2013 |
| Z-2609-2016 | Class II | 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled… | Oct 7, 2013 |
| Z-0392-2014 | Class II | Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL… | Sep 25, 2013 |
| Z-0189-2014 | Class II | SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision… | Sep 24, 2013 |
| Z-0143-2014 | Class II | Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on… | Sep 10, 2013 |
| Z-0099-2014 | Class II | Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated… | Sep 4, 2013 |
| Z-0109-2014 | Class II | Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of… | Aug 30, 2013 |
| D-831-2013 | Class II | DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container… | Jul 24, 2013 |
| Z-1945-2014 | Class II | Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis. | Jul 8, 2013 |
| Z-0197-2014 | Class II | SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled… | Jun 10, 2013 |
| Z-1610-2013 | Class II | Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day Infusor… | Jun 7, 2013 |
| Z-1609-2013 | Class II | Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV… | Jun 7, 2013 |
| Z-1606-2013 | Class II | Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications. | Jun 7, 2013 |
| Z-1605-2013 | Class II | Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous administration of… | Jun 7, 2013 |
| Z-1604-2013 | Class II | Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications. | Jun 7, 2013 |
| Z-1603-2013 | Class II | Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications. | Jun 7, 2013 |
| Z-1602-2013 | Class II | Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous… | Jun 7, 2013 |
| Z-1601-2013 | Class II | Brand Name: Multirate Infusor Devices. Indicated for the intravenous administration of… | Jun 7, 2013 |
| Z-1600-2013 | Class II | Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous… | Jun 7, 2013 |
| Z-1565-2013 | Class II | Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis… | May 21, 2013 |
| D-629-2013 | Class II | Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL… | May 21, 2013 |
| D-628-2013 | Class II | Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC… | May 21, 2013 |
| D-627-2013 | Class II | Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL, Rx… | May 21, 2013 |
| D-626-2013 | Class II | Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex… | May 21, 2013 |
| D-625-2013 | Class II | 5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC… | May 21, 2013 |
| D-624-2013 | Class II | 0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100… | May 21, 2013 |
| Z-1684-2013 | Class II | Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code… | May 15, 2013 |
| Z-1683-2013 | Class II | Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code… | May 15, 2013 |
| Z-1682-2013 | Class II | Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013… | May 15, 2013 |
| Z-1271-2013 | Class II | A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer… | Mar 28, 2013 |
| Z-1270-2013 | Class II | A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7"… | Mar 28, 2013 |
| Z-1269-2013 | Class II | A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection… | Mar 28, 2013 |
| Z-1268-2013 | Class II | A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock… | Mar 28, 2013 |
| D-623-2013 | Class II | 0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter… | Feb 27, 2013 |
| Z-2474-2015 | Class II | CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with… | Feb 25, 2013 |
| Z-2473-2015 | Class II | MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use with Baxter Locking… | Feb 25, 2013 |
| Z-2472-2015 | Class II | MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. intended for… | Feb 25, 2013 |
| Z-2471-2015 | Class II | MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483… | Feb 25, 2013 |
| Z-2687-2016 | Class II | Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an… | Dec 14, 2012 |
| D-1690-2012 | Class II | Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC… | Sep 21, 2012 |
| D-1689-2012 | Class II | 0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC… | Sep 21, 2012 |
| D-1688-2012 | Class II | 5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only… | Sep 21, 2012 |
| D-1687-2012 | Class II | 10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare… | Sep 21, 2012 |
| D-1686-2012 | Class II | 5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC… | Sep 21, 2012 |
| Z-0015-2013 | Class I | Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette… | Sep 7, 2012 |
| Z-0014-2013 | Class I | Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette… | Sep 7, 2012 |
| Z-0013-2013 | Class I | Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip… | Sep 7, 2012 |
| Z-0012-2013 | Class I | Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a… | Sep 7, 2012 |
| Z-2142-2012 | Class I | AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition… | Jul 13, 2012 |
| Z-2141-2012 | Class I | AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition… | Jul 13, 2012 |
| Z-2140-2012 | Class I | AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders… | Jul 13, 2012 |
| Z-2139-2012 | Class I | AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; Product… | Jul 13, 2012 |
| Z-1490-2012 | Class I | Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700… | Jul 6, 2011 |
| Z-2269-2012 | Class III | Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with… | Mar 4, 2011 |
| Z-2268-2012 | Class III | Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump… | Mar 4, 2011 |
| Z-1679-2013 | Class II | Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver… | Jul 31, 2009 |
| Z-1678-2013 | Class II | Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver… | Jul 31, 2009 |
| Z-1677-2013 | Class II | Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver… | Jul 31, 2009 |