BEUDAMED
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    Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code IYE·September 13, 2016

    BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

    FDA Recall
    Terminated ·BIOTRONIK Inc·Product code MRM·March 8, 2021

    BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

    FDA Recall
    Terminated ·BIOTRONIK Inc·Product code LWS·March 8, 2021

    Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HBF·October 16, 2020

    M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall

    FDA Recall
    Terminated ·New Wave Endo-Surgical, Corp.·Product code HCF·July 8, 2020

    Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery

    FDA Recall
    Terminated ·Teleflex Medical·Product code HCF·March 24, 2016

    Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

    FDA Recall
    Terminated ·Teleflex Medical·Product code HCF·November 16, 2016

    Box labeled in part, "REF: 72-1000***IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5")(L) RABALON, STAINLESS STEEL, GOLD PLATED***NON-STERILE PRODUCT*** MADE IN THE PHILIPPINES*** BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" The Biomet Microfixation IQ Intelligent Driver is a handheld cordless device designed for three functions: drill pilot holes, high-speed insertion of 1.5x4mm titanium screws, and high-speed insertion of 1.5x4mm and 1.5x5mm Lactosorb fixation screws provided by Biomet Microfixation. The IQ Intelligent Driver is indicated to aid in the implantation of screws (Drilling holes and inserting screws).

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code HBF·July 8, 2011

    DeVilbiss Model DV5x Series CPAP with Heated Humidifier Device is intended to treat Obstructive Sleep Apnea (OSA) in patients weighing 30 Kg and above. The device creates a positive pressure in the patient's airway to prevent collapse of the airway while the patient is sleeping. The heated humidifier provides additional humidity to the air supplied to the patient. The heated humidifier has a removable water chamber for filling with water and ease of cleaning.

    FDA Recall
    Terminated ·Sunrise Medical HHG Inc. dba DeVilbiss Healthcare·Product code BZD·March 11, 2011

    STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal spray, item number 1010300

    FDA Recall
    Terminated ·HF Acquisition Co., LLC·Product code LRR·June 4, 2020

    STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical emergencies until EMS arrives.

    FDA Recall
    Terminated ·HF Acquisition Co. LLC·Product code LRR·June 5, 2020

    STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan Nasal spray, item number 1010300

    FDA Recall
    Terminated ·HF Acquisition Co., LLC·Product code LRR·June 4, 2020

    STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal spray, item number 1010300

    FDA Recall
    Terminated ·HF Acquisition Co., LLC·Product code LRR·June 4, 2020

    HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place West/Mukilteo, WA 98275, HealthFirst.com; Store at Room Temperature. 9036-2v.5 08/2017 containing various products to include Narcan Nasal spray, item number 1010300

    FDA Recall
    Terminated ·HF Acquisition Co., LLC·Product code LRR·June 4, 2020

    Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.

    FDA Recall
    Terminated ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQI·February 24, 2016

    Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers.

    FDA Recall
    Terminated ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ITW·February 24, 2016

    Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.

    FDA Recall
    Terminated ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code KQZ·March 14, 2016

    Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.

    FDA Recall
    Terminated ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code KQZ·March 14, 2016

    Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black

    FDA Recall
    Terminated ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IPY·February 24, 2016

    Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.

    FDA Recall
    Terminated ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code KQZ·March 14, 2016