BEUDAMED
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    PERCUTANEOUS CATHETER INTRODUCER ADAPTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACUMED

    FDA UDI
    Acumed LLC·10806378043512·2.0mm Hexalobe Lkg Drill Guide 4-32mm

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE CANADA KIRKLAND·Product code IOR·May 8, 2014

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KXA·October 22, 2012

    SM104 MSERIES W5TH WHL

    FDA Adverse Event
    Malfunction ·STRYKER CORP, MEDICAL DIV·Product code FPO·August 3, 2010

    Detachol adhesive remover, 4 fl oz (118 mL), Marketed by Eloquest Healthcare, Inc., a Ferndale Pharma Group company, Manufactured by Ferndale Laboratories, Inc., Ferndale, MI 48220 U.S.A.

    FDA Recall
    Terminated ·Ferndale Laboratories, Inc.·Product code KOX·July 7, 2010

    H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code BTR·July 7, 2014

    H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code BTR·July 7, 2014

    H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code BTR·July 7, 2014

    H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code BTR·July 7, 2014

    4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code BTR·July 7, 2014

    H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code BTR·July 7, 2014

    Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·October 16, 2012

    HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·October 16, 2012

    Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.

    FDA Recall
    Terminated ·B Braun Medical Inc·Product code KDI·April 1, 2016

    Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.

    FDA Recall
    Terminated ·B Braun Medical Inc·Product code KDI·April 1, 2016

    Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.

    FDA Recall
    Terminated ·B Braun Medical Inc·Product code KDI·April 1, 2016