BEUDAMED
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    Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.

    FDA Recall
    Terminated ·Helena Laboratories, Corp.·Product code GFO·January 5, 2021

    Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.

    FDA Recall
    Terminated ·Helena Laboratories, Corp.·Product code GFO·December 7, 2017

    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

    FDA Recall
    Terminated ·ITC-Nexus Dx·Product code GFO·December 19, 2013

    Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GFO·July 18, 2006

    Staclot LA 20 (REF 00594) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GFO·November 14, 2018

    Staclot LA (REF 00600) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GFO·November 14, 2018

    Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation procedures requiring an activated partial thromboplastin reagent.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code GFO·March 25, 2015

    Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials

    FDA Recall
    Terminated ·Dade Behring Inc. Rte 896, Glasgow Business Community·Product code GFO·March 1, 2004

    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

    Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits

    FDA Enforcement
    Class II ·Terminated·DeRoyal Industries Inc·July 25, 2012

    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

    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 Recall
    Terminated ·Alivecor SFO·Product code DXH·January 9, 2015

    Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·September 26, 2012

    Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy

    FDA Enforcement
    Class II ·Terminated·DeRoyal Industries Inc·February 28, 2018

    GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical

    FDA Enforcement
    Class II ·Terminated·DeRoyal Industries Inc·July 17, 2013

    Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.

    FDA Enforcement
    Class II ·Terminated·DeRoyal Industries Inc·September 7, 2016

    DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Heart Pack A&B Pgybk, ref 89-7750.02 4) Open Heart Pack A&B Pgybk, ref 89-7750.03 5) Intl-Cardiac Surgery Pack A&B Pgybk, ref 89-8514.02 GEO-MED sterile custom surgical kits: 1) Open Heart Pack Pgybk, ref 89-5792.10 2) Open Heart A&B Pgybk, ref 89-7626.02 3) Open Heart A&B Pgybk, ref 89-7626.03 4) Open Heat Pack A&B Pgybk, ref 89-8440.01 5) Open Heart Pack A&B Pgybk, ref 89-8440.02

    FDA Enforcement
    Class II ·Terminated·DeRoyal Industries Inc·December 9, 2015

    Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.

    FDA Recall
    Terminated ·Ivoclar A. G. Fl-9494 Schaan Liechtenstein·Product code EBC·October 7, 2015

    Drop Arm Versamode"

    FDA Enforcement
    Class II ·Terminated·Gf Health Products·April 14, 2021

    The device is SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog # SP3000146-ST used for removal of calculi, fragments of medical devices and other foreign objects uring urological or gatroenterological procedures. The device has the manufacturer listed on the label which is Scion Cardio-Vascular, Inc., 14256 SW 119 Avenue, Miami, FL 33186.

    FDA Recall
    Terminated ·Scion Cardio-Vascular, Inc.·Product code FGO·June 30, 2003