BEUDAMED
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    BECK'S CLASSIC

    FDA registration
    BECK'S CLASSIC·2 products·🇺🇸 United States

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·January 13, 2011

    DIAMOND BACK 360 CLASSIC 2.0MM

    FDA Adverse Event
    Injury ·CARDIOVASCULAR SYSTEMS INCORPORATED·Product code MCX·March 1, 2023

    C. S. I. DIAMOND BACK CORONARY CLASSIC

    FDA Adverse Event
    Injury ·CSI PRODUCTS (CARDIOVASCULAR SYSTEMS) INCORPORATED·Product code MCX·May 3, 2019

    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.

    FDA Enforcement
    Class II ·Terminated·Owen Mumford USA, Inc.·July 22, 2015

    Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. Angiographic x-ray system.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code JAA·January 15, 2013

    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.

    FDA Recall
    Terminated ·Owen Mumford USA, Inc.·Product code FMF·December 11, 2014

    Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee Systems Primary Cruciate-Retaining & Cruciate-Substituting Procedure Surgical Technique,SP2-007 Product Usage: The SP2 IM Rod is used in both primary and revision Sigma knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included in both the SP2 and HP instrument kits.

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code LXH·February 5, 2013

    Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the FlexNeck PD Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC System of peritoneoscopic implantation enable inspection of the peritoneum to confirm the presence of adhesions and to avoid them, all patients who are suitable for PD can receive this catheter.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code FJS·December 20, 2017

    Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model # 46-240838G2, manufactured after March 8, 1985 for Advantx Legacy, RFX and SFX systems. General-purpose radiographic system component used to suspend the system's image monitor.

    FDA Recall
    Terminated ·GE Healthcare·Product code IZO·March 9, 2007