BEUDAMED
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    ARTHROCARE FLOW CONTROL UNIT

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

    QUANTUM™ Couch Top

    FDA UDI
    Qfix·10841962109083·Quantum Couchtop, 2000mm

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964015968·Endo Carry-On Procedure Kit

    GRADIA®

    FDA UDI
    Gc America Inc.·D0470019041·GRADIA® gum Modifier (GM35), 2.4 mL

    GRADIA®

    FDA UDI
    Gc America Inc.·14548161393263·GRADIA® gum Modifier (GM35), 2.4 mL

    SCANLAN® Easy-Tag™ Tracking System

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159002775·Easy-Tag, Black, Spool of 250

    CastleLoc Pectus Bar System Instrument Set

    FDA UDI
    L&K BIOMED CO. ,LTD.·08809986460325·EZ Crane System 4

    WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PENADAPT 10

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

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·June 10, 2020

    TALENT THORACIC STENT GRAFT SYSTEM (CT)

    FDA Adverse Event
    Malfunction ·MEDTRONIC CARDIOVASCULAR·Product code MIH·October 7, 2010

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·March 13, 2013

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·July 3, 2014

    CONTAK RENEWAL 3 RF HE

    FDA Adverse Event
    Death ·CLONMEL·Product code NIK·February 22, 2008

    SMARTXIDE 50 HS

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 30, 2023

    CryoValve, Pulmonary Valve & Conduit SG

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·August 18, 2003

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024