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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)
Nov 23, 2020Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
Open, Classified
FRNK042121
Nov 23, 2020Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
Open, Classified
FRNK042121
Oct 22, 2020Baxter Healthcare Corporation
Spectrum IQ Infusion System with Dose IQ Safety Software
Terminated
FRNK173084
Oct 22, 2020Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Terminated
FRNK133801
Oct 22, 2020Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Terminated
FRNK133801
Oct 22, 2020Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
Terminated
FRNK042121
Sep 4, 2020CareFusion 303, Inc.
PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2, TC10013702 ASSY, CAS
Open, Classified
FRNK133532
Sep 4, 2020CareFusion 303, Inc.
BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652
Open, Classified
FRNK043299
K133532
Sep 4, 2020CareFusion 303, Inc.
Alaris System PC Unit Model 8015
Open, Classified
FRNK133532
Aug 19, 2020CareFusion 303, Inc.
Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amou
Open, Classified
FRNK133532
Aug 19, 2020CareFusion 303, Inc.
Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual s
Open, Classified
FRNK133532
Aug 19, 2020CareFusion 303, Inc.
Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual ste
Open, Classified
FRNK133532
Aug 19, 2020CareFusion 303, Inc.
Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual
Open, Classified
FRNK133532
Aug 19, 2020CareFusion 303, Inc.
Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual st
Open, Classified
FRNK133532
Aug 6, 2020CareFusion 303, Inc.
Alaris Pump Module Model 8100
Terminated
FRNK133532
Aug 6, 2020CareFusion 303, Inc.
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
Terminated
FRNK133532
Aug 6, 2020CareFusion 303, Inc.
Alaris System PC Unit Model 8000 modular infusion pump and monitoring system
Terminated
FRNK133532
Aug 6, 2020Smiths Medical ASD Inc.
Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
Open, Classified
FRNK040899
K111386
Aug 6, 2020Smiths Medical ASD Inc.
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Open, Classified
FRNK040899
K111386
Aug 6, 2020CareFusion 303, Inc.
Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
Terminated
FRNK133532
Aug 6, 2020CareFusion 303, Inc.
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
Terminated
FRNK133532
Aug 6, 2020CareFusion 303, Inc.
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Terminated
FRNK133532
Aug 6, 2020CareFusion 303, Inc.
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Terminated
FRNK133532
Aug 6, 2020CareFusion 303, Inc.
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Terminated
FRNK133532
Aug 6, 2020CareFusion 303, Inc.
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Terminated
FRNK133532
Aug 6, 2020CareFusion 303, Inc.
Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
Terminated
FRNK133532
Aug 6, 2020CareFusion 303, Inc.
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
Terminated
FRNK133532
Aug 4, 2020CareFusion 303, Inc.
BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
Open, Classified
FRNK133532
Jul 30, 2020CME America, LLC
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable r
Terminated
FRNK080954
Jul 30, 2020CME America, LLC
CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through c
Terminated
FRNK080954
Jul 30, 2020CME America, LLC
CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptab
Terminated
FRNK080954
Jul 30, 2020CME America, LLC
CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically accepta
Terminated
FRNK080954
Jul 30, 2020CME America, LLC
CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically accept
Terminated
FRNK080954
Jul 30, 2020CME America, LLC
CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable r
Terminated
FRNK080954
Mar 18, 2020CME America, LLC
CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
Terminated
FRNK061325
Mar 11, 2020CME America, LLC
BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids int
Terminated
FRNK042696
Mar 5, 2020CareFusion 303, Inc.
CareFusion Alaris PCA Module, Model 8120
Open, Classified
FRNK012383
K051641
Mar 5, 2020CareFusion 303, Inc.
CareFusion Alaris Syringe Module, Model 8110
Open, Classified
FRNK012383
K051641
Mar 5, 2020CareFusion 303, Inc.
CareFusion Alaris Pump Module, Model 8100
Open, Classified
FRNK012383
K051641
Mar 5, 2020CareFusion 303, Inc.
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
Open, Classified
FRNK133532
Feb 27, 2020CME America LLC
CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/* Lot Number Label: BODYGUARD LOT 2019-0364 Manufacturing Date: 20
Terminated
FRNK042696
Dec 12, 2019Smiths Medical ASD Inc.
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient
Terminated
FRNK111386
Oct 22, 2019ICU Medical Inc
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
Terminated
FRNK161469
Aug 12, 2019Fenwal Inc
VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare f
Terminated
FRNK121613
Jul 29, 2019ICU Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 un
Terminated
FRNNone listed
Jul 29, 2019ICU Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 un
Terminated
FRNNone listed
Jul 29, 2019ICU Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL. 1 unit p
Terminated
FRNNone listed
Jul 29, 2019ICU Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit pe
Terminated
FRNNone listed
Jul 29, 2019ICU Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit pe
Terminated
FRNNone listed
Jul 29, 2019ICU Medical Inc
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set, 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter
Terminated
FRNNone listed

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