BEUDAMED
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    Well Lead Extraction Bag

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VISITAG SURPOINT External Processing Unit

    FDA UDI
    Biosense Webster Inc·10846835017885·External Processing Unit

    eTRAX™ Needle

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436103343·Sterile needle, 16GA x 8cm with (7.6 tapered to...

    n/a

    FDA UDI
    Ortho Development Corporation·00822409070497·Snap-on Fem Augment Trial 8mm Distal Size 6

    n/a

    FDA UDI
    Ortho Development Corporation·00822409067367·Stem Extension Trial Diameter 16x80mm

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER INC.·Product code LPB·March 22, 2019

    PUMA MODEL VERSION 1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEKNA-LOK MODEL BP1000V2L

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    RIATA ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·SST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·July 7, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC.·Product code LPB·May 14, 2019

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·April 8, 2019

    CROSSCATH SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·March 6, 2019

    CROSSCATH SUPPORT CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·February 26, 2019

    CROSSCATH SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·June 20, 2019

    Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 3, 2013

    Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 4, 2018

    Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For atomization of topical solutions across the naso and oropharyngeal mucosal membranes

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016

    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 6, 2017