BEUDAMED
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    Flosonics Medical (R/A 1929803 Ontario Corp.)

    Manufacturer
    🇨🇦 Canada·1 Basic UDI-DI·1 Device

    FLOSONICS MEDICAL (R/A 1929803 ONTARIO CORP.)

    FDA registration
    FLOSONICS MEDICAL (R/A 1929803 ONTARIO CORP.)·1 product·🇨🇦 Canada

    BLOOD FLOW VELOCIMETERS

    Device
    EU MDR · Eu Md Class 2a ·Flosonics Medical (R/A 1929803 Ontario Corp.)·On the market·32 countries

    FloPatch FP120

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Flosonics Medical (R/A 1929803 Ontario Corp.)·1 device

    FloPatch FP120, REF: FP120-FOT01-005

    FDA Enforcement
    Class III ·Ongoing·Flosonics Medical (R/A 1929803 ONTARIO CORP.)·September 10, 2025

    FloPatch FP120, REF: FP120-FOT01-005

    FDA Recall
    Open, Classified ·Flosonics Medical (R/A 1929803 ONTARIO CORP.) Fourth Floor, Oneeleven 325 Front St W Toronto Canada·Product code DPW·August 7, 2025

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices

    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, perioperative and postoperative regional anesthesia and pain management. It is a controller that allows the user to regulate the amount of medication that is dispensed.

    FDA Recall
    Terminated ·I-Flow Corporation·Product code MEB·April 15, 2011

    Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.

    FDA Recall
    Terminated ·Viscot Medical LLC·Product code FZZ·August 22, 2012

    Model 4000 CMS Ambulatory Infusion Pump, Model Number: 350-1101

    FDA Recall
    Terminated ·Curlin Medical Llc·Product code FRN·May 30, 2008

    PainSmart, PainSmart IOD Ambulatory Infusion System, Model Number: 360-1301

    FDA Recall
    Terminated ·Curlin Medical Llc·Product code FRN·May 30, 2008

    Model 2000 CMS/ Model 2000 Plus Ambulatory Infusion Pump, Model Number: 340-1001

    FDA Recall
    Terminated ·Curlin Medical Llc·Product code FRN·May 30, 2008

    Model 4000 Plus Ambulatory Infusion Pump, Model Number: 350-1001

    FDA Recall
    Terminated ·Curlin Medical Llc·Product code FRN·May 30, 2008

    Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz, 600 VA MOD EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-240V~50/60 Hz, 600VA MOD EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-240V~50/60 Hz, 600VA MOD EPIQ DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only,100-240V~50/60 Hz, 600VA

    FDA Recall
    Terminated ·Philips Ultrasound Inc·Product code IYN·December 16, 2020

    CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FMG·August 29, 2025

    TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.

    FDA Recall
    Open, Classified ·Guangzhou Wondfo Biotech Co., Ltd.·Product code DIS·May 18, 2018

    TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.

    FDA Recall
    Open, Classified ·Guangzhou Wondfo Biotech Co., Ltd.·Product code DIS·May 18, 2018

    TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.

    FDA Recall
    Open, Classified ·Guangzhou Wondfo Biotech Co., Ltd.·Product code DIS·May 18, 2018

    Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code KFM·December 3, 2019

    The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14

    FDA Recall
    Open, Classified ·Circulatory Technology Inc.·Product code DTN·April 27, 2021