BEUDAMED
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    PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code KDI·June 17, 2014

    Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.

    FDA Recall
    Terminated ·Ethicon, Inc. US·Product code GAP·October 17, 2014

    Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella.

    FDA Recall
    Terminated ·Remel Inc·Product code JSK·October 17, 2014

    Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and / or promoting relaxation of muscle.

    FDA Recall
    Terminated ·Pivotal Health Solutions·Product code ILY·December 17, 2014

    nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.

    FDA Recall
    Terminated ·NordicNeuroLab AS Mollendalsveien 65c Bergen Norway·Product code LLZ·September 17, 2014

    Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc.

    FDA Recall
    Terminated ·Sakura Finetek USA Inc·Product code KEO·April 16, 2014

    Terumo Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 17, 2014

    Terumo Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 17, 2014

    Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code HTO·September 17, 2014

    K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support.

    FDA Recall
    Terminated ·Breg Inc·Product code IQI·March 14, 2014

    Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85

    FDA Recall
    Terminated ·Philips Medical Systems, Inc.·Product code MQB·March 17, 2014

    Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support.

    FDA Recall
    Terminated ·Breg Inc·Product code IQI·March 14, 2014

    McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.

    FDA Recall
    Terminated ·Mckesson Medical Immaging Suite 130-10711 Cambie Road Richmond Canada British Columbia·Product code LLZ·April 17, 2014

    Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

    FDA Recall
    Terminated ·Aesculap, Inc.·Product code JXG·December 17, 2014

    The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication based on patient demand.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code MEA·April 17, 2014

    Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LON·October 17, 2014

    Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures in vascular surgery.

    FDA Recall
    Terminated ·Mallinckrodt Manufacturing LLC·Product code NBE·October 17, 2014

    Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LON·October 17, 2014