BEUDAMED
    94 results · 31ms · Sources: EU EUDAMED, US FDA

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    BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.

    FDA Enforcement
    Class II ·Terminated·BD Biosciences, Systems & Reagents·July 9, 2014

    1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 for orthopedic use.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·April 4, 2018

    Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.

    FDA Enforcement
    Class I ·Terminated·Maquet Datascope Corp - Cardiac Assist Division·May 28, 2014

    Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.

    FDA Recall
    Terminated ·Bard Access Systems·Product code IYN·June 21, 2011

    HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul, MN 55110, Part Number HMK-RM

    FDA Recall
    Terminated ·Porous Media Corporation·Product code BTT·April 26, 2007

    Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·March 21, 2014

    Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·April 20, 2016

    Pulsavac Fan Spray Kit ,Catalog #00-5150-475-01; 1kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio

    FDA Recall
    Terminated ·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007

    Pulsavac Plus AC Fan Spray Kit, Catalog #00-5150-476-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio

    FDA Recall
    Terminated ·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007

    1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 for orthopedic use.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FQH·November 9, 2017

    BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code OYE·June 6, 2014

    Pulsavac Plus Low Pressure Fan Spray Kit, Catalog #00-5150-975-00, 10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio

    FDA Recall
    Terminated ·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007

    Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients.

    FDA Recall
    Terminated ·Respironics California Inc·Product code CBK·October 29, 2014

    0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·July 22, 2015

    Pulsavac Plus Wound Debridement System, Fan Spray Kit , Catalog #00-5150-475-00, 10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio

    FDA Recall
    Terminated ·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007

    Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, Kidney, Renal Cavity and Renal Calyces. The instrument is introduced via percutaneous cut when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 6, 2016

    Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·January 8, 2020

    Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·January 8, 2020

    Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code KKX·January 7, 2016

    Xoran MiniCAT CT Scanner ID ENT00001

    FDA Recall
    Terminated ·Xoran Technologies, Inc.·Product code JAK·December 14, 2009