BEUDAMED
    100 results · 12ms · Sources: EU EUDAMED, US FDA

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    Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.

    FDA Recall
    Terminated ·C.R. Bard, Inc.·Product code EZD·September 14, 2017

    LoFric Origo, Tiemann, 16in, FR14 urinary catheters

    FDA Recall
    Terminated ·Wellspect HealthCare (Division of DENTSPLY IH AB) Aminogatan 1 Molndal Sweden·Product code EZD·June 17, 2020

    Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.

    FDA Recall
    Terminated ·Cure Medical LLC·Product code EZD·September 19, 2012

    Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers: 50612, 50614, 50616, 50618, 52306, 52308, 52310, 52606, 52606G, 52608, 52608G, 52610, 52610G, 53314, 53320, 53514G, 53610, 53610G, 53612G, 53614G, 53616G, 53618G, 62308, 62310, 62606P, 602608, 62608P, 62610, 62610P, 63310, 63316, 63610, 63610M, 63612, 63612M, 63614, 63614M, 63616, 63616M, 63618, 71410, 72608, 72610, 73612, 73614, 73616 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.

    FDA Recall
    Terminated ·C.R. Bard, Inc.·Product code EZD·September 14, 2017

    Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F* Carton Label UPC (P10) *+M405P105H* The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. Intended to be used by pediatric males and females for the purpose of bladder drainage

    FDA Recall
    Terminated ·Cure Medical LLC·Product code EZD·November 11, 2014

    LoFric Origo, Tiemann, 16in, FR12 urinary catheters

    FDA Recall
    Terminated ·Wellspect HealthCare (Division of DENTSPLY IH AB) Aminogatan 1 Molndal Sweden·Product code EZD·June 17, 2020

    HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.

    FDA Recall
    Terminated ·C.R. Bard, Inc.·Product code EZD·September 14, 2017

    LoFric Origo, Nelaton, 16in, FR10 urinary catheters

    FDA Recall
    Terminated ·Wellspect HealthCare (Division of DENTSPLY IH AB) Aminogatan 1 Molndal Sweden·Product code EZD·June 17, 2020

    SureCath Set with Accessories, Coloplast Corp.-MN 06093, Sterile EO., Manufacturer Coloplast -A/S 3050 Denmark. 28022S 1400 SureCath Set,acc CH8 Male,bulk 28023S 1400 Surecath Set,acc CH10 Male,bul 28024S 1400 Surecath Set,acc CH12 Male,bul 280320 1400 SureCath Set,acc CH14 Male 28032S 1400 Surecath Set,acc CH14 Male,bul 28036S 1400 Surecath Set,acc CH14/1,2 Male 28037S 1400 Surecath Set,acc CH16 Male 280370 1400 Surecath Set,acc CH16 Male 28033S 1400 Surecath Set,acc CH16 Male 280360 1400 Surecath Set,acc CH14/1,2 Male 280340 1400 SURECATH SET W.ACC FEM14` The SureCath Set is indicated for use by patients for intermittent catherization for the purpose of bladder drainage. The insertion supplies provided are to be used to insert the catheter using sterile technique.

    FDA Recall
    Terminated ·Coloplast Manufacturing US, LLC·Product code EZD·April 21, 2011

    VisuaLine Tricyclic Antidepressants: Six Dip (COC-THC-OPI-MET-BZD-OXD); Six Dip (COC-THC-OPI-MET-PCP-OXD); Eight DIP (COC-THC-OPI-MET-AMP-BAR-BZD-OXD); Nine Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA); Ten Dip X (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-TCA); Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-OXD); Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA-OXD); Five Dip (COC-THC-OPI-BZD-OXD); and Six Dip (CPC-THC-OPI-MET-AMP-OXD). Product is intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.

    FDA Recall
    Terminated ·Sun Biomedical Laboratories, Inc.·Product code DJR·May 28, 2008

    Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x. Lava Ultimate for Straumann milling centers 1334x. Lava Ultimate CAD/CAM Restorative for TS150, Compatible with TS150 (IOS Technologies), Glidewell Laboratories, 2614x. Lava Ultimate Restorative with Blue Mandrel, Pedestal Mandrel, compatible with Carestream CS 3000, Roland DWX-50, Roland DWX-4, 1314x, 2012x, 2110x. Lava Ultimate Restorative for Planmill, Compatible with Planmill mills, same mandrel format as E4D, 4212x, 4214x, 4312x, 4414x, 5072x, 5074x. Lava Ultimate Restorative for Ceramill, Compatible with Ceramill mills manufactured by Amann Girrbach, 4514x, 4714x, 5044x. Frame/Blank Version Used by Dental Laboratories: Lava Ultimate Implant Crown Restorative, Compatible with Lava Milling Equipment (Lava blocks bonded into frames. These are also known as blanks.), 69140-69149, 69150-69159, 69160-69163.

    FDA Enforcement
    Class II ·Terminated·3M Company - Health Care Business·July 15, 2015

    Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640

    FDA Enforcement
    Class III ·Terminated·Diamedix Corporation·August 8, 2018

    DrugCheck 8 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP Product Code 60800

    FDA Recall
    Terminated ·Drug Free Enterprises Inc·Product code DIO·March 20, 2003

    DrugCheck 9 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP/TCA Product Code 60900

    FDA Recall
    Terminated ·Drug Free Enterprises Inc·Product code DIO·March 20, 2003

    DrugCheck 9 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP/MTD Product Code 60925

    FDA Recall
    Terminated ·Drug Free Enterprises Inc·Product code DIO·March 20, 2003

    Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.

    FDA Enforcement
    Class II ·Terminated·Diamedix Corporation·May 25, 2016

    Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film Device

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code LLZ·February 23, 2006

    Hudson RCI One Way Valve, 22mm E.D. to 22mm O.D., REF 1665, Rx Only, Teleflex Medical, Research Triangle park, NC 27709

    FDA Recall
    Terminated ·Telefelx Medical·Product code BZA·December 2, 2009

    AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Analyte Cut off Device Code Marijuana THC 50 ng/mL THC Cocaine Benzoylecgonine 300 ng/mL COC Amphetamine Amphetamine 1000 ng/mL AMP Methamphetamine Methamphetamine 1000 ng/mL MET Opiates Morphine 2000 ng/mL OPI Opiates300 Morphine 300 ng/ml OPI300 Phencyclidine Phencyclidine 25 ng/mL PCP Barbiturates Secobarbital 300 ng/mL BAR Benzodiazepines Oxazepam 300 ng/mL BZD Methadone Methadone 300 ng/mL MTD Oxycodone Oxycodone 100 ng/mL OXY MDMA MDMA 500 ng/mL MDMA Tricyclic Antidepressants Nortriptyline 1000 ng/mL TCA

    FDA Enforcement
    Class III ·Terminated·Branan Medical Corporation·August 10, 2016

    Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA); e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA); f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA); g. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA)

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·March 21, 2018