Panels › General Hospital › Product code MEB · Class 2
Pump, Infusion, Elastomeric
Regulation 880.5725
1510(k)s in 12 months (88 all time)
0recalls in 12 months (109 all time)
94recalls that name a 510(k)
Top companies in MEB
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Instruments Div. of Stryker Corporation | 0 | 46 |
| I-Flow Corp. | 17 | 11 |
| Baxter Healthcare Corp | 8 | 10 |
| Arrow International Inc | 0 | 17 |
| Symbios Medical Products, LLC | 3 | 12 |
| Novacon Corp. | 6 | 0 |
| Advanced Infusion, Inc. | 5 | 0 |
| Breg, Inc. | 5 | 0 |
| Hsmg, Inc. D/b/a Smartinfuser Usa | 0 | 4 |
| B.Braun Medical, Inc. | 1 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2019 | Leventon S. A. U. DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA
Provide parenteral drug infusions at a constant flow without impeding patient mobility Terminated |
MEB | None listed |
| Oct 2, 2018 | Arrow International Inc AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | K090300 |
| Oct 2, 2018 | Arrow International Inc AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | K090300 |
| Oct 2, 2018 | Arrow International Inc AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | K090300 |
| Oct 2, 2018 | Arrow International Inc AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | K090300 |
| Oct 2, 2018 | Arrow International Inc AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | K090300 |
| Oct 2, 2018 | Arrow International Inc AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | K090300 |
| Oct 2, 2018 | Arrow International Inc AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL CPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | K090300 |
| Oct 2, 2018 | Arrow International Inc AF 550 x 5ML/HR CPNB, Product code MC0050XL CPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | K090300 |
| Oct 2, 2018 | Arrow International Inc AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | K090300 |
| Oct 2, 2018 | Arrow International Inc AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | K090300 |
| Oct 2, 2018 | Arrow International Inc AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | K090300 |
| Oct 2, 2018 | Arrow International Inc AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | K090300 |
| Oct 2, 2018 | Arrow International Inc 0F 550 x 8ML/HR 2ML 60LO CPNB, Product code MT8060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | None listed |
| Oct 2, 2018 | Arrow International Inc AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | K090300 |
| Oct 2, 2018 | Arrow International Inc AF550x5ML/H 2ML 60LO 6" CATH, 4.5" IN, Product code MT5060XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | K090300 |
| Oct 2, 2018 | Arrow International Inc AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | K090300 |
| Oct 2, 2018 | Arrow International Inc AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | K090300 |
| Sep 16, 2014 | B. Braun Medical, Inc. B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device.
AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administratio Terminated |
MEB | K081905 |
| Feb 3, 2014 | B. Braun Medical, Inc. B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML
Generally used for delivery of antibiotic and local anesthesia medications. Terminated |
MEB | K081905 |
| Jul 10, 2013 | Baxter Healthcare Corp. Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication thera Terminated |
MEB | K071222 |
| Jul 10, 2013 | Baxter Healthcare Corp. Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication thera Terminated |
MEB | K071222 |
| Jul 10, 2013 | Baxter Healthcare Corp. Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication thera Terminated |
MEB | K071222 |
| Jun 27, 2013 | Baxter Healthcare Corp. Brand Name: Intermate Infusion Pump.
Indicated for the intravenous administration of medications. Terminated |
MEB | K943664 |
| Jun 27, 2013 | Baxter Healthcare Corp. Brand Name: Regional Analgesia Infusor System with Patient Control.
Indicated for the intravenous administration of medications. Terminated |
MEB | K051253 |
| Jun 27, 2013 | Baxter Healthcare Corp. Brand Name: Multirate Infusor Devices.
Indicated for the intravenous administration of medications. Terminated |
MEB | K011317 |
| Jun 27, 2013 | Baxter Healthcare Corp. Brand Name: Infusor SV and LV Elastomeric Infusion Devices.
Indicated for the intravenous administration of medications. Terminated |
MEB | K071222 |
| Jun 27, 2013 | Baxter Healthcare Corp. Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device
Device Listing: D020871
Baxter's lnfusors SV Elastomeric Infusion Device i Terminated |
MEB | K062457 |
| Jun 6, 2013 | Symbios Medical Products, LLC Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr. Delivery time 60 to 144 hours; found in the following kits:
GoBlock Kit 510646,
Disposable Infusi Terminated |
MEB | None listed |
| Jun 6, 2013 | Symbios Medical Products, LLC Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits
GoBlock Kit 510612,
Disposable Infusion Pump for drug delivery. Symbios GOBl Terminated |
MEB | None listed |
| Jun 6, 2013 | Symbios Medical Products, LLC Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits
GoBlock Kit 510612,
Disposable Infusion Pump for drug delivery. Symbios GOBl Terminated |
MEB | None listed |
| Jun 6, 2013 | Symbios Medical Products, LLC Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per side)( 6mL/hr ),... found in the following kits
GoBlock Kit 510491,
Disposable Single Infusion Pump for drug delivery Terminated |
MEB | None listed |
| Jun 6, 2013 | Symbios Medical Products, LLC Part 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr ),... found in the following kits
GoBlock Kit 510458,
Disposable Single Infusion Pump Terminated |
MEB | None listed |
| Jun 6, 2013 | Symbios Medical Products, LLC Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... found in the following kits
GoBlock Kit 510472,
Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System Terminated |
MEB | None listed |
| Jun 6, 2013 | Symbios Medical Products, LLC Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side,... found in the following kits
GoPump Kit 510462-BP, 5 " catheter & BIOPATCH
GoPump Kit 510558-BP 10 " catheter& BIOPA Terminated |
MEB | None listed |
| Jun 6, 2013 | Symbios Medical Products, LLC Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...sterile.. found in the following kits
GoPump Kit 510203-BP, Epidural catheter & BIOPATCH
GoPump Kit 510204, 2.5" Fenestra Terminated |
MEB | None listed |
| Jun 6, 2013 | Symbios Medical Products, LLC Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... found in : GoPump Kit 510201-BP, 5 fenestrated catheter & BIOPATCH;
Go Pump Kit 510349-BP, Epidural Catheter, Bi Terminated |
MEB | None listed |
| Jun 6, 2013 | Symbios Medical Products, LLC Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side,... Sterile, found in the following kits: GoPump kit 510080-BP, 5 fenestrated catheter & BIOPATCH; Terminated |
MEB | None listed |
| Jun 6, 2013 | Symbios Medical Products, LLC Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME: 150mL, 2 mL/hr continuous
Delivery Time : App. 72 hrs when filled to capacity
Sterile EO... found in the follow Terminated |
MEB | None listed |
| Mar 13, 2013 | Symbios Medical Products, LLC GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL elastomeric reservoirs, each of which conn Terminated |
MEB | K072921 |
| Oct 30, 2012 | First Medical Source LLC Medpro Elastomeric Infusion Pump.
AccuFlux, Model # CT-0020-100H.
Product Usage:
The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or e Terminated |
MEB | K081905 |
| Aug 28, 2012 | I-Flow Corporation ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1 Terminated |
MEB | K023318 |
| Nov 23, 2011 | Wolf Medical Supply Inc. Wolf Medical Supply Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 270 mL, FLOW RATE 2mL/Hr.
Model # CT-0020-270 Item # RFC270020.
Manufactured by Medpro International (Thailand) L Terminated |
MEB | K081905 |
| Nov 23, 2011 | Wolf Medical Supply Inc. Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 100 mL, FLOW RATE 2mL/Hr. Model # CT-0020-100 Item # RFC100020.
Manufactured by Medpro International (Tha Terminated |
MEB | K081905 |
| Nov 23, 2011 | Wolf Medical Supply Inc. Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 60 mL, FLOW RATE 2mL/Hr, Model # CT-0020-060 Item # RFC060020. Manufactured by Medpro International (Thailand) L Terminated |
MEB | K081905 |
| Oct 24, 2011 | Victus, Inc. "***Vipat REF H0020-100***Lot 100533***2015-04***STERILE EO Elastomeric pump***2mL/Hr***100mL***Medpro International (Thailand) Ltd. 360, Moo 6, Chonburi Industrial Estate, Tambon Bowin, Amphur Srirac Terminated |
MEB | None listed |
| Oct 24, 2011 | Progressive Medical Inc Medpro AccuFlo Elastomeric Infusion Device, Model #CT-0020-270C, packaged 12/box. The box label shows the product is Manufactured By: Medpro International (Thailand) Ltd. for Medpro Corporation Pte. Terminated |
MEB | K081905 |
| Jul 28, 2011 | I-Flow Corporation I-Flow ON-Q with Select-A-Flow Pumps,
Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for preoperative, periope Terminated |
MEB | K063530 |
| May 5, 2011 | Baxter Healthcare Corp. Baxter Single Day Infusor 2 mL/h Portable Elastomeric Infusion System; an Rx sterile disposable drug delivery system; Baxter Healthcare Corporation, Deerfield, IL 60015; REF 2C1071KJP
The Infusor devi Terminated |
MEB | K982102 |
| Apr 14, 2011 | Hsmg, Inc. D/b/a Smartinfuser Usa SmartInfuser PainPump, Part numbers: P49220-S, P49230-S, P49230-SD, P49234-S, and P49234-SD. Terminated |
MEB | K042122 K061409 |
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