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Panels › General Hospital › Product code NEP · Class 2

System/Device, Pharmacy Compounding

Regulation 880.5440

0510(k)s in 12 months (0 all time)
2recalls in 12 months (42 all time)
8recalls that name a 510(k)
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Top companies in NEP

DateFirm and productCodeLinked 510(k)
May 29, 2026Baxter Healthcare Corporation
Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on connector on one end (to attach to the Fluid Selector Valve
Open, Classified
NEPK002705
May 13, 2026Omnicell, Inc.
Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20M
Open, Classified
NEPNone listed
May 22, 2023OmniCell, Inc.
Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
Open, Classified
NEPNone listed
Jul 22, 2022Baxter Healthcare Corporation
ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192
Terminated
NEPNone listed
Apr 21, 2021Smiths Medical ASD Inc.
ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures.
Terminated
NEPNone listed
Apr 21, 2021Smiths Medical ASD Inc.
Left Heart Kit, Model Number M20268. for blood pressure monitoring.
Terminated
NEPNone listed
Nov 23, 2020B Braun Medical, Inc.
APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
Terminated
NEPNone listed
Nov 23, 2020B Braun Medical, Inc.
APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
Terminated
NEPNone listed
Nov 23, 2020B Braun Medical, Inc.
APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
Terminated
NEPNone listed
Jun 4, 2018B. Braun Medical, Inc.
26-Lead Transfer Set for use with APEX Compounding System, Product Catalog Number 2112550
Terminated
NEPK151423
Jan 10, 2017HEALTH ROBOTICS S.R.L.
i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448
Terminated
NEPNone listed
Jun 23, 2016The Metrix Company
Container fill and transfer sets, 250 mL and 500 mL, . .
Terminated
NEPNone listed
Jun 23, 2016The Metrix Company
Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL
Terminated
NEPK960581
Jun 23, 2016The Metrix Company
Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mL
Terminated
NEPK926123
Jun 23, 2016The Metrix Company
Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL.
Terminated
NEPK843523
Jun 23, 2016The Metrix Company
Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL.
Terminated
NEPK030888
Jun 23, 2016The Metrix Company
AUTOCOMP6 High Speed Compounder
Terminated
NEPNone listed
Jun 23, 2016The Metrix Company
AUTOCOMP6 XP High Speed Compounder REF 58810
Terminated
NEPNone listed
Jun 23, 2016The Metrix Company
AUTOCOMP6 XPS High Speed Compounder REF 58810
Terminated
NEPNone listed
Mar 8, 2016ICU Medical, Inc.
Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prio
Terminated
NEPNone listed
Mar 8, 2016ICU Medical, Inc.
Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions
Terminated
NEPNone listed
Mar 8, 2016ICU Medical, Inc.
Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to
Terminated
NEPNone listed
Mar 8, 2016ICU Medical, Inc.
Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prio
Terminated
NEPNone listed
Mar 8, 2016ICU Medical, Inc.
Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST, ASN222-R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solution
Terminated
NEPNone listed
Mar 8, 2016ICU Medical, Inc.
Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to
Terminated
NEPNone listed
Nov 30, 2015Baxter Healthcare Corp.
Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a medicinal product from one container to another conta
Terminated
NEPNone listed
May 18, 2015Baxter Corporation Englewood
ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total parente
Terminated
NEPNone listed
Jun 22, 2014Baxter Corporation Englewood
Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.
Terminated
NEPNone listed
May 12, 2014Baxter Corporation Englewood
ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 A
Terminated
NEPNone listed
Dec 29, 2013Baxter Healthcare Corp.
IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the orders.
Terminated
NEPNone listed
Oct 25, 2012Baxa Corporation
Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device are Fluid Transfer Tube Sets, Sterile/EO, Std Volume Tri
Terminated
NEPNone listed
Aug 8, 2012Baxter Healthcare Corp.
AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement
Terminated
NEPNone listed
Aug 8, 2012Baxter Healthcare Corp.
AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement f
Terminated
NEPNone listed
Aug 8, 2012Baxter Healthcare Corp.
AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compoundi
Terminated
NEPNone listed
Aug 8, 2012Baxter Healthcare Corp.
AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding de
Terminated
NEPNone listed
Apr 9, 2012Baxa Corporation
Pharmacy compounding system . It is a twenty-four source compounder for multi-source fluid mixing of both macro and micro ingredient down to 0.2 ml quantities. Product Usage: Pharmacy compounding Sy
Terminated
NEPNone listed
Apr 5, 2012Baxa Corporation
The EM 2400 is a Pharmacy Compounding System consisting of three sub-systems for compounding solutions for intravascular administration. Pharmacy compounding system for mixing ingredients for intrava
Terminated
NEPNone listed
Aug 19, 2008Baxa Corporation
Exacta-Mix 600 Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients into on final solution based on user-specified sequences and volumes.
Terminated
NEPNone listed
Aug 19, 2008Baxa Corporation
Exacta-Mix 2400, Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients into on final solution based on user-specified sequences and volumes.
Terminated
NEPNone listed
Sep 27, 2007Baxa Corporation
Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112.
Terminated
NEPNone listed
Jul 20, 2004Baxter Healthcare Corp.
Clintec Micromix Compounder, an I.V. solution compounder; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA; product code 2M8290 - 1.0 mL accuracy, and product code 2M
Terminated
NEPK955622
Jul 20, 2004Baxa Corporation
Exacta-Mix 2400 pharmacy compounding system.
Terminated
NEPK002705

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