ClearanceBrief
Panels › General Hospital › Product code FRN · Class 2

Pump, Infusion

Regulation 880.5725

2510(k)s in 12 months (849 all time)
24recalls in 12 months (724 all time)
672recalls that name a 510(k)
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Top companies in FRN

DateFirm and productCodeLinked 510(k)
Aug 11, 2009Hospira Inc
Hospira Phoenix Infusion System with MedNet Software, Symbiq Two-Channel Infusion System, Software versions v2.1 & v3.0, Manufactured by Hospira Inc., Morgan Hill, CA
Terminated
FRNK041550
Aug 11, 2009Hospira Inc
Hospira Phoenix Infusion System with MedNet Software, Symbiq One-Channel Infusion System, Software versions v2.1 & v3.0, Manufactured by Hospira Inc., Morgan Hill, CA.
Terminated
FRNK041550
Aug 3, 2009Cardinal Health 303 dba Cardinal Health
Alaris System Inter-Unit Interface (IUI) Connectors. The Modules include the following: Alaris PC Unit, Model Numbers 8000 and 8015; Alaris Pump Module, Model 8100; Alaris Patient-Controlled Analges
Terminated
FRNK012383
K023264 +3
Aug 3, 2009Cardinal Health 303 dba Cardinal Health
Alaris Pump Module, Model 8100.
Terminated
FRNK950419
Aug 3, 2009Cardinal Health 303 dba Cardinal Health
The Alaris PC Unit, Model 8015 (manufactured or serviced between April 2008 and January 2009). The Alaris PC Unit is the central programming and power supply component for the Alaris System modules.
Terminated
FRNK051641
Aug 3, 2009Cardinal Health 303 dba Cardinal Health
The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) software version 8 and above when used with the Alaris PCA Module (Model 8120). The Alaris PC Unit is the central programming
Terminated
FRNK012383
K051641
Aug 3, 2009Cardinal Health 303 dba Cardinal Health
The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) with software version 4 and above.
Terminated
FRNK012383
K051641
May 1, 2009Cardinal Health 303 dba Cardinal Health
Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120 used with the Alaris PC Unit with software versions 8 through 9.1.
Terminated
FRNK012383
K032233
Apr 30, 2009Stryker Instruments Div. of Stryker Corporation
Stryker PainPump2, 400 mL PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 541-155. The Stryker PainPump2 is an electromechani
Terminated
FRNK043466
Apr 30, 2009Stryker Instruments Div. of Stryker Corporation
Stryker PainPump2, 400 mL PainPump with Luer Lock Tubing Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 540-350. The Stryker PainPump2 is an electromechanical pump designed to deliver a control
Terminated
FRNK043466
Apr 30, 2009Stryker Instruments Div. of Stryker Corporation
Stryker PainPump2, 250 mL PainPump with 5.0 inch ExFen 2-Site Catheter Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 525-50. The Stryker PainPump2 is an electromechanical pump designed to deli
Terminated
FRNK043466
Apr 30, 2009Stryker Instruments Div. of Stryker Corporation
Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen 2-Site Catheter Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 525-25. The Stryker PainPump2 is an electromechanical pump designed to deli
Terminated
FRNK043466
Apr 30, 2009Stryker Instruments Div. of Stryker Corporation
Stryker PainPump2, 250 mL Pre-Set PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 521-155. The Stryker PainPump2 is an electr
Terminated
FRNK043466
Apr 30, 2009Stryker Instruments Div. of Stryker Corporation
Stryker PainPump2, 250 mL Pre-Set PainPump with Luer Lock Tubing Set, 2.5 inch ExFen and Standard Catheter, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 521-125. The Stryker PainPump2 is an electr
Terminated
FRNK043466
Apr 30, 2009Stryker Instruments Div. of Stryker Corporation
Stryker PainPump2, 400 mL PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 540-155. The Stryker PainPump2 is an electromechani
Terminated
FRNK043466
Apr 30, 2009Stryker Instruments Div. of Stryker Corporation
Stryker PainPump2, 400 mL PainPump with 5.0 inch ExFen 2 Site Catheter Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 540-50. The Stryker PainPump2 is an electromechanical pump designed to deli
Terminated
FRNK043466
Apr 30, 2009Stryker Instruments Div. of Stryker Corporation
Stryker PainPump2, 400 mL PainPump with 2.5 inch ExFen 2 Site Catheter Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 540-25. The Stryker PainPump2 is an electromechanical pump designed to deli
Terminated
FRNK043466
Apr 30, 2009Stryker Instruments Div. of Stryker Corporation
Stryker PainPump2, 250 mL PainPump with Luer Lock Tubing Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 525-350. The Stryker PainPump2 is an electromechanical pump designed to deliver a control
Terminated
FRNK043466
Apr 30, 2009Stryker Instruments Div. of Stryker Corporation
Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen Catheter and Luer Lock Tubing Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 525-158. The Stryker PainPump2 is an electromechanical pump d
Terminated
FRNK043466
Apr 30, 2009Stryker Instruments Div. of Stryker Corporation
Stryker PainPump2, 250 mL PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 525-155. The Stryker PainPump2 is an electromechani
Terminated
FRNK043466
Apr 30, 2009Stryker Instruments Div. of Stryker Corporation
Stryker PainPump2, 250 mL PainPump with Luer Lock Tubing Set, 2.5 inch ExFen and Standard Catheter, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 525-125. The Stryker PainPump2 is an electromechani
Terminated
FRNK043466
Apr 7, 2009Cardinal Health 303 dba Cardinal Health
ReadyMed Elastomeric Ambulatory Pump, Model Numbers: R050050, R100100, R100200, R250050, R250100, and R250167. Intended for self-administration of anti-microbial and antiviral agents.
Terminated
FRNK895797
K913658
Mar 9, 2009Smiths Medical MD, Inc.
Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V4.1.5. A small, lightweight and portable syringe infusion pump. The Medfusion 3500 syringe pump is indicated for use w
Terminated
FRNK040899
Mar 9, 2009Smiths Medical MD, Inc.
Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V3.0.6. A small, lightweight and portable syringe infusion pump. The Medfusion 3500 syringe pump is indicated for use w
Terminated
FRNK040899
Mar 2, 2009Baxter Healthcare Corp.
Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore. Product codes: 2M8153, 2M8163,
Terminated
FRNK063696
Mar 2, 2009Baxter Healthcare Corp.
Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore. Product Codes: 2M8151, 2M8161,
Terminated
FRNK063696
Feb 27, 2009Hospira Inc
Symbiq One-Channel list number 16026-04 and Two-Channel list number 16027-04 Infusion System, a general purpose infuser, Distributed and Manufactured by Hospira Inc, Morgan Hill, CA. Is a general pur
Terminated
FRNK041550
Feb 2, 2009Stryker Instruments Div. of Stryker Corporation
Stryker PainPump Two Site Infusion Set, sterile, 10 per box. Manufactured for Stryker Instruments, Kalamazoo, MI. Product number 0500-200-000, REF 500-200. A disposable syringe infuser which uses su
Terminated
FRNK042405
Feb 2, 2009Stryker Instruments Div. of Stryker Corporation
Stryker PainPump Two Site Infusion Kit with ExFen 5.0", 120 mL Infusion Kit, sterile, 5 per box. Manufactured for Stryker Instruments, Kalamazoo, MI. Product number 0500-166-050, REF 500-166-50. A d
Terminated
FRNK042405
Feb 2, 2009Stryker Instruments Div. of Stryker Corporation
Stryker PainPump, Two Site Infusion Kit with ExFen 2.5", 120 mL Infusion Kit, sterile, 5 per box. Manufactured for Stryker Instruments, Kalamazoo, MI. Product Number 0500-166-025, REF 500-166-25. A
Terminated
FRNK042405
Jan 27, 2009Stryker Instruments Div. of Stryker Corporation
Stryker PainPump 2 Blockaid, 400 mL PainPump for Continuous Nerve Block, sterile, 5 per box. Stryker, Kalamazoo, MI; REF 575-100, Product Number 0575-100-000. The device is used to deliver controlle
Terminated
FRNK043466
Oct 21, 2008Baxter Healthcare Corp.
Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A. Indicated for infusion via intravenous, intra-arte
Terminated
FRNK945942
Sep 23, 2008B. Braun Medical, Inc.
Safeline Metriset w/Cassette, inj sties, clamps LL 114 in. Item/Catalog number 375122. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Out
Terminated
FRNK904518
K921860
Sep 23, 2008B. Braun Medical, Inc.
Adult Metriset w/Cassette 2 inj sites, LL 120 in. Item/Catalog number 375043. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Saf
Terminated
FRNK904518
K921860 +1
Sep 23, 2008B. Braun Medical, Inc.
Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj sites, B/C valve 120 in. Item/Catalog number 375040. The product is shipped 20 units per carton. The product i
Terminated
FRNK904518
K921860 +1
Sep 23, 2008Smiths Medical MD, Inc.
Deltec Micro 3100 Large Volume Infusion Pump, CE 0473, RX Only, Smiths Medical MD, Inc. 1265 Grey Fox Road, St. Paul, MN 55112, USA, Made in UK. Reorder number 21-5311-01 The product is used for gene
Terminated
FRNK940446
Sep 23, 2008Smiths Medical MD, Inc.
Deltec 3000 Large Volume Infusion Pump, CE 0473, RX Only, Smiths Medical MD, Inc. 1265 Grey Fox Road, St. Paul, MN 55112, USA, Made in UK. Reorder numbers 21-5301-01 & 21-5306-01 The product is us
Terminated
FRNK940446
Sep 22, 2008Curlin Medical Llc
PainSmart, PainSmart IOD Ambulatory Infusion System, Model Number: 360-1301
Terminated
FRNK981816
Sep 22, 2008Curlin Medical Llc
Model 6000 CMS, CMS IOD, or Plus Ambulatory Infusion Pump, Model Number: 360-1101
Terminated
FRNK981816
Sep 22, 2008Curlin Medical Llc
Model 4000 CMS Ambulatory Infusion Pump, Model Number: 350-1101
Terminated
FRNK981816
Sep 22, 2008Curlin Medical Llc
Model 4000 Plus Ambulatory Infusion Pump, Model Number: 350-1001
Terminated
FRNK981816
Sep 22, 2008Curlin Medical Llc
Model 2000 CMS/ Model 2000 Plus Ambulatory Infusion Pump, Model Number: 340-1001
Terminated
FRNK981816
Aug 24, 2008Smiths Medical MD, Inc.
CADD-MS"3 Ambulatory Infusion Pumps, Model 7400, Rx only, CE 0473, SN 499000. The device is designed for subcutaneous, intravenous, epidural and intrathecal infusion of medication. Reorder Numbers
Terminated
FRNK051568
Aug 15, 2008Smiths Medical MD, Inc.
CADD-MS 3 Ambulatory Infusion Pump, Model 7400 Smiths Medical MD, Inc., St. Paul, MN 55112 USA. Electromechanical pumps used for general drug delivery infusion therapies. Used mainly by home care p
Terminated
FRNK051568
Jun 10, 2008Cardinal Health 303 Inc DBA Alaris Products
U9 Socket Integrated Circuit ("U9 IC") on the display board of the following Alaris System modules built on or before October 4, 2005: (1) Alaris Syringe module (Model 8110) (a.k.a. Medley Syringe mod
Terminated
FRNK010966
K012383 +4
Jun 10, 2008Cardinal Health 303 Inc DBA Alaris Products
Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March 26, 2004: (1) Alaris PC point-of-care unit ("PC Unit") (Model 8000)* (a.k.a. Medley PC Uni
Terminated
FRNK010966
K012383 +4
Jun 10, 2008Cardinal Health 303 Inc DBA Alaris Products
U19 Socketed Integrated Circuit ("U19 IC") on the logic board of Alaris Pump modules (aka. Medley Pump modules), Model 8100 built on or before September 8, 2005. CardinalHealth, San Diego, CA 92130
Terminated
FRNK012383
K950419
Feb 26, 2008Smiths Medical MD, Inc.
Smiths Medical CADD-Sentry Pro Medication Safety Software - electronic pump protocol programming software - Administrator REF 21-6275-51 RX only, Smiths Medical MD, Inc. St Paul, Minnesota 55112 USA
Terminated
FRNK062892
Feb 13, 2008Smiths Medical MD, Inc.
Smiths CADD Yellow Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml, Reorder No.21-7100-24, Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112
Terminated
FRNK843772
Feb 13, 2008Smiths Medical MD, Inc.
Smiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml., Reorder No. 21-7002-24 , Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112
Terminated
FRNK843772

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