BEUDAMED
    29 results · 13ms · Sources: EU EUDAMED, US FDA

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    Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2 Line LTerm Lng , Adt/Pedi Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line High Humidity , Neo/Inf Intub CO2 Line LTerm Lng , VitaLine H Set Adult/Pediatric , VitaLine H Set Infant/Neonatal , FilterLine Set Long Adult/Pediatric , FilterLine H Set Long Adult/Pediatric , FilterLine H Set Long Infant/Neonatal , Trade Compliant: FilterLine H, Adult/Ped , Trade Compliant: FilterLine H, Infant/Neo , FilterLine Set Adult/Pedi , FilterLine H Set Adult/Pedi and FilterLine H Set Infant/Neonatal. Carbon dioxide gas analyzer.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code CCK·April 7, 2025

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS40

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code BTO·May 29, 2024

    NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software, packaged in a portable field case. Eye-tracking headset system is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects. The EYE-SYNC is intended to record, measure, and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI).

    FDA Recall
    Open, Classified ·NeuroSync, Inc.·Product code QEA·September 19, 2023

    NEO DELTA SELFSAFE PUR T, I.V. Catheter:

    FDA Recall
    Open, Classified ·Delta Med SpA Via Guido Rossa 20 Viadana Italy·Product code FOZ·June 21, 2021

    GE Heathcare Giraffe OmniBed; neo natal incubator

    FDA Recall
    Open, Classified ·DATEX--OHMEDA, INC.·Product code FMZ·September 3, 2024

    NEO DELTA Self Safe, I.V. Catheter REF 3738222

    FDA Recall
    Open, Classified ·Delta Med SpA Via Guido Rossa 20 Viadana Italy·Product code FOZ·June 21, 2021

    NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122

    FDA Recall
    Open, Classified ·Delta Med SpA Via Guido Rossa 20 Viadana Italy·Product code FOZ·June 21, 2021

    NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code JAY·October 20, 2022

    NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822

    FDA Recall
    Open, Classified ·Delta Med SpA Via Guido Rossa 20 Viadana Italy·Product code FOZ·June 21, 2021

    NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units

    FDA Recall
    Open, Classified ·Delta Med SpA Via Guido Rossa 20 Viadana Italy·Product code FOZ·June 21, 2021

    NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522

    FDA Recall
    Open, Classified ·Delta Med SpA Via Guido Rossa 20 Viadana Italy·Product code FOZ·June 21, 2021

    GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator

    FDA Recall
    Open, Classified ·DATEX--OHMEDA, INC.·Product code FMZ·September 3, 2024

    Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

    FDA Recall
    Open, Classified ·Mercury Enterprises, Inc. dba Mercury Medical·Product code BTL·August 30, 2024

    AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.

    FDA Recall
    Open, Classified ·SonarMed Inc·Product code OQU·March 21, 2024

    AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.

    FDA Recall
    Open, Classified ·SonarMed Inc·Product code OQU·March 21, 2024

    AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.

    FDA Recall
    Open, Classified ·SonarMed Inc·Product code OQU·March 21, 2024

    Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in ophthalmology and in other disciplines with vertical direction of view

    FDA Recall
    Open, Classified ·Haag-Streit USA Inc·Product code HRM·November 20, 2020

    regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code MLS·December 26, 2024

    Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842

    FDA Recall
    Open, Classified ·Mercury Enterprises, Inc. dba Mercury Medical·Product code BTL·December 10, 2024

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code BTO·May 29, 2024