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    ULTRA-VUE SPINAL TYPE BIOPSY NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    K2-HF OPAQUE DENTIN, OD-C1, 50g.

    FDA UDI
    Yeti Dentalprodukte GmbH·EYET38626100·

    Shoreline ACS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981144739·Modular Trial 16x14x10mm, 15 Deg Lordosis, w/ D...

    NEXA Negative Pressure Wound Therapy System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CARE-E-VAC 3

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 22, 2014

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 10, 2012

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·June 23, 2015

    Basin Pack, part number AMS2497

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 1, 2014

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·July 19, 2017

    Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Medtronic SynchroMed EL Programmable Pumps, Models 8626-10, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·August 3, 2007

    Medtronic SynchroMed EL Programmable Pump, Model 8626-10. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.-- (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site)

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·August 3, 2007

    Medtronic - SynchroMed EL Implantable Infusion Pump, Model Number: 8626-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·January 16, 2008

    Medtronic SynchroMed EL Programmable Pump, Model 8626-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·August 25, 2008

    SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter. The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids referred to in this manual.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·November 9, 2012

    SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter. The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids referred to in this manual.

    FDA Enforcement
    Class I ·Terminated·Medtronic Neuromodulation·December 19, 2012

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026