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    Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva is intended to be used as a multifunctional/universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Reproductive system, Respiratory system, Circulatory system, Various:Arthrograms, Myelograms, Facet joint injections, Discography, Sialography

    FDA Recall
    Terminated ·Philips Medical Systems, Inc.·Product code KPR·September 24, 2014

    Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at the FCC authorized medical device frequency of 27.12 MHz. Provant transmits a fixed dose of non-ionizing, non-thermal RF energy via an applicator pad that is placed adjacent to the patient's dressed wound. The Provant Wound Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

    FDA Recall
    Terminated ·Regenesis Biomedical Inc·Product code ILX·September 29, 2008

    Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A, (2) 15A Resettable CB: Tested and complies with FCC Part 15 Class A. OptiMedica 1310 Moffett Park Drive Sunnyvale, CA 94089 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.

    FDA Recall
    Terminated ·Optimedica Corporation·Product code OOE·December 20, 2013

    Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper FD2O, 722008 Allura Xper FD2O Biplane, 722010 Allura Xper FD1O, 722011 Allura Xper FD1O/10, 722012 Allura Xper FD2O, 722013 Allura XPER FD2O BIPLANE, 722014 Allura Xper FD1O OR Table, 722015 Allura Xper FD2O OR Table, 722019 Allura Xper FD1O/10 OR Table, 722020 Allura Xper FD2O Biplane OR Table, 722022 Allura Xper FD1O OR Table, 722023 Allura Xper FD2O OR Table, 722024 Allura Xper FD1O/10 OR Table, 722025 Allura Xper FD2O Biplane OR Table, 722026 Allura Xper FD1O, 722027 Allura Xper FD1O/10, 722028 Allura Xper FD2O, 722029 Allura Xper FD2O/10, 722031 Allura CV2O, 722033 Allura Xper FD1O OR Table, 722034 Allura Xper FD1O/10 OR Table, 722035 Allura Xper FD2O OR Table, 722036 Allura Xper FD2O/10 OR Table, 722038 Allura Xper FD2O/20, 722039 Allura Xper FD2O/20 OR Table, 722058 Allura Xper FD20115, 722059 Allura Xper FD2O/15 OR Table, 722123 Field extensions Xper cardio systems, 722124 Field extensions Xper vascular systems, 722126 SmartPath to AlluraClarity cardio, 722127 SmartPath to AlluraClarity vascular, 722133 Field ext. Xper cardio systems R7.6, 722134 Field ext. Xper vascular systems R7.6, 722400 Cardio Vascular-Allura Centron, 889006 Diamond Select Allura Xper FD1 0 The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Tis included, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper FD series is compatible with a hybrid Operating Room. FD10 is compatible with specific magnetic navigation systems

    FDA Recall
    Terminated ·Philips Medical Systems, Inc.·Product code IZI·September 24, 2014

    AccuSure Insulin Syringe, 1cc, 28 guage, 1/2'', packaged in boxes of 100, each containing 10 bundles of 10 syringes, disposable, NDC 0603-6996-21.

    FDA Recall
    Terminated ·Qualitest Pharmaceuticals Inc·Product code FMF·June 14, 2005

    Live Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe short needle. 100 syringes, Manufactured by UltiCare. Used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock or saline lock.

    FDA Recall
    Terminated ·Ulti Med, Inc.·Product code FMF·February 5, 2010

    NIPRO, GLUCOPRO INSULIN SYRINGES, SINGLE USE INSULIN SYRINGE with needle, 1CC 30g 5/16", U-100 INSULIN, LATEX FREE. Distributed by: NIPRO MEDICAL CORPORATION 3150 N.W. 107th Ave., Miami, Florida 33172. Packaged 10 syringes in a pouch, 10 pouches in a box (100 pieces), 5 boxes in a case (500 pieces). JD+01U3008-5C 1cc 30G x 5/16"; JD+01U3013-5C 1cc 30G x 1/2"; JD+01U3108-5C 1cc 31G x 5/16"; JD+03U3008-5C .3CC 30 g X 5/16"; JD+03U3013-5C .3CC 30 g X 1/2"; JD+03U3108-5C .3cc 31G x 516"; JD+05U3008-5C .5cc 30G x 5/16"; JD+05U3013-5C .5cc 30G x 1/2"; JD+05U3108-5C .5cc 31G x 5/16".

    FDA Recall
    Terminated ·Nipro Medical Corporation·Product code FMF·January 13, 2010

    Product is labeled in part - Pouch label: "***ORTHOFIX***Manufactured By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: Origen***DBM Paste***Size***REF:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***" Product is labeled in part - Carton label: "***Origen DBM with Bioactive Glass***REF***ID***Expiration***Manufactured for Blackstone Medical, Inc by: Nanotherapeutics, Inc. 13859 Progress Blvd. suite 300 Alachua, FL 32615***Distributed By: Orthofix Inc 1720 Bray Central Drive McKinney, TX 75069***Rx Only***ONE EACH***" Origen DBM with Bioactive Glass Catalog #: 22-2002 (2cc size) 22-2005 (5cc size) 22-2010 (10cc size) "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis).

    FDA Recall
    Terminated ·Nanotherapeutics, Inc·Product code MQV·March 10, 2011

    Product is labeled in part - Pouch label: "***NanoFUSE***DBM***Manufactured and Distributed By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: nanoFUSE DBM***Size***Order No.:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***nanotherapeutics***" Product is labeled in part - Carton label: "***nanoFUSE DBM***Order No:***ID***Expiration***nanotherapeutics***Manufactured and Distributed By: Nanotherapeutics, Inc. 13859 Progress Blvd. Suite 300 Alachua, FL 32615***Rx Only***ONE EACH***" NanoFUSE DBM Catalog #: NAN109-02 (2cc size) NAN109-05 (5cc size) NAN109-10(10cc size) "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis).

    FDA Recall
    Terminated ·Nanotherapeutics, Inc·Product code MQV·March 10, 2011

    Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler

    FDA Recall
    Terminated ·Surgical Tissue Network, Inc.·Product code MQV·March 14, 2012

    Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30

    FDA Recall
    Terminated ·Exactech, Inc.·Product code MQV·April 26, 2019

    Cook Polyvinyl Alcohol Foam (PVA ) Embolization Particles, particle size 47-90 microns, 1 cc; order number PVA-50.

    FDA Recall
    Terminated ·Cook, Inc.·July 1, 2003

    Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 180-300 microns, 1 cc; order number PVA-200.

    FDA Recall
    Terminated ·Cook, Inc.·July 1, 2003

    Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 710-1000 microns, 1 cc; order number PVA-700.

    FDA Recall
    Terminated ·Cook, Inc.·July 1, 2003

    Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 300-500 microns, 1 cc; order number PVA-300.

    FDA Recall
    Terminated ·Cook, Inc.·July 1, 2003

    Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 500-710 microns, 1 cc; order number PVA-500.

    FDA Recall
    Terminated ·Cook, Inc.·July 1, 2003

    Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 90-180 microns, 1 cc; order number PVA-100.

    FDA Recall
    Terminated ·Cook, Inc.·July 1, 2003

    ReliOn Insulin syringes - 1cc, 31 G Distributed by: Can-Am Care, Corp., Alpharetta, GA

    FDA Recall
    Terminated ·Product code FMI·October 9, 2008

    AccuSure, U-100, 31Gauge, 1/2cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7001-21, packaged 10 syringes per package, 10 packages per carton

    FDA Recall
    Terminated ·Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals·Product code FMF·August 21, 2009

    AccuSure, U-100, 31Gauge, 1cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7002-21, packaged 10 syringes per package, 10 packages per carton

    FDA Recall
    Terminated ·Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals·Product code FMF·August 21, 2009