BEUDAMED
    21 results · 27ms · Sources: EU EUDAMED, US FDA

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    BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964015920·Endo Carry-On Procedure Kit

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489105626·PowerChem Neoprene Exam Gloves, Small

    IFAK

    FDA UDI
    FARETEC, INC.·B54170019020·Tactical Medical Kit-Med Op, custom, coyote

    GRADIA®

    FDA UDI
    Gc America Inc.·14548161393249·GRADIA® gum Modifier (GM33), 2.4 mL

    GRADIA®

    FDA UDI
    Gc America Inc.·D0470019021·GRADIA® gum Modifier (GM33), 2.4 mL

    Baby Gorilla®/Gorilla® Plating System

    FDA UDI
    Paragon 28, Inc.·00889795034922·MTP Spin Guard™ Female Reamer, 19mm

    No Mix30

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746061325·NO MIX:30 ACTIVATOR 15 GMS

    No Mix30

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746007798·NO MIX:30 ACTIVATOR 15 GMS

    WAKO LIPASE CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    KLINIDRAPE REINFORCED SURGICAL GOWNS

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

    CastleLoc Pectus Bar System Instrument Set

    FDA UDI
    L&K BIOMED CO. ,LTD.·08809986460301·EZ Crane System 2

    WVSM Wireless Vital Signs Monitor

    FDA UDI
    ATHENA GTX, INC.·B3944670019020·A/C Power Cord

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 20, 2025

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 13, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 12, 2014

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Death ·ZOLL LIFECOR CORPORATION·Product code MVK·February 21, 2008

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024