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

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    ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Synergy

    FDA UDI
    Rmo, Inc.·00885797100948·DOLICH SY 185 HK MX/3 5-5 20EA

    GRADIA®

    FDA UDI
    Gc America Inc.·14548161075466·GRADIA® DIRECT LoFlo - 2 syringes (1.3 g/0.8 m...

    GRADIA®

    FDA UDI
    Gc America Inc.·D0470022901·GRADIA® DIRECT LoFlo - 2 syringes (1.3 g/0.8 m...

    POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)

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

    LAZERSMILE, LAZERWHITE

    FDA 510(k)
    FDA Class 1 ·Dental

    TITAN CATHETER

    FDA Adverse Event
    Malfunction ·MEDICAL COMPONENTS, INC.·Product code MSD·November 5, 2019

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·March 13, 2013

    FMP HIP

    FDA Adverse Event
    Malfunction ·ENCORE MEDICAL, L.P.·Product code LPH·January 26, 2011

    SYNCHROMED EL

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code LKK·February 22, 2008

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 6, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 6, 2024

    DISP.TROCAR THRD.W.DILATING PIN 12/110MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG·Product code GCJ·July 9, 2019

    LIPOSUCTION PACK AESTHETIC SURG.CENTER CONTENTS: (1) BLADE SURG. #11 CARBON STEEL (3) * GLOVE PERRY SURG. # 7LATEX (15) SPONGE LAP PREWASH 18" X 18" XRD L/F (4) * GLOVE PERRY SURG. # 7 LATEX (1) TABLE COVER REINF 50" X 90" LIF (2) GOWN SOFT SMS STD XL SET IN SLEEVE L/F (4) DRAPE SHEET 44" X 58" SMS LIF (1) TRAY ORGANIZER FULL DEEP (3) SHEET% 53" X 77" REINF. LIF (2) TOWELS ABSORBENT 15" X 20" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    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

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018

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

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