BEUDAMED
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    AMPLATZER PFO Occluder. Order No. 9-PFO-018. Device is not PMA approved in the US. 18mm Sterile EO. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code MLV·June 1, 2006

    AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm Sterile EO. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code MLV·June 1, 2006

    B Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The product is packaged as 50 bulk nonsterile units per pouch, 2 pouches per shipping carton.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code DYB·May 8, 2006

    Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet Achieva 1.5T, Model 781492, 4) Magnet HFO, Model 781495, 5) Magnet Multiva 16, Model 781496, 6) Magnet Multiva 8, Model 781497 & 7) Magnets Ingenia 1.5T CX, Model 781498 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·April 25, 2018

    Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).

    FDA Enforcement
    Class III ·Terminated·Alivecor SFO·February 25, 2015

    ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code LJS·October 20, 2014

    Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code GCB·October 20, 2014

    ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code DWM·October 20, 2014

    ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code DWM·October 20, 2014

    ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code FJS·October 20, 2014

    Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code GCB·October 20, 2014

    PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.

    FDA Recall
    Terminated ·Pro-Dex Inc·Product code GEY·September 25, 2018

    Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code GCB·October 20, 2014

    Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code LJS·October 20, 2014

    6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter.

    FDA Recall
    Terminated ·Pfm Medical Inc·Product code LJS·October 20, 2014

    Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Recall
    Terminated ·Pro-Dex Inc·Product code MOQ·December 23, 2015

    Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Recall
    Terminated ·Pro-Dex Inc·Product code MOQ·December 23, 2015

    Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Enforcement
    Class II ·Terminated·Pro-Dex Inc·March 23, 2016

    Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Enforcement
    Class II ·Terminated·Pro-Dex Inc·March 23, 2016

    ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.

    FDA Enforcement
    Class II ·Terminated·Pfm Medical Inc·December 17, 2014