BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal

    FDA Recall
    Open, Classified ·T.G. Eakin Limited·Product code EXE·August 8, 2024

    Spectrum IQ Infusion Pump, Product Code 3570009

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·July 14, 2025

    Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product Code CMABATT; and Starling Patient Cable, Product code CMASC10.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code DSB·September 2, 2022

    Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code OZD·May 31, 2024

    FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for orthopedic surgical procedures to remove and collect debris and bone fragments, chips, cement, marrow and blood clots without blocking the suction device, using a combination of suctioning and filtering.

    FDA Recall
    Open, Classified ·ConvaTec, Inc·Product code JOL·January 9, 2019

    Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into the stomach or duodenum to assist in the drainage of gastric contents, decompression of the stomach or duodenum, or for obtaining a specimen of gastric contents. The device is intended to administer medication or fluids, and enteral feeding.

    FDA Recall
    Open, Classified ·ConvaTec, Inc·Product code FPD·January 9, 2019

    Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the removal of debris, particulates or wound tissue. Typically, forceps may be used in conditions where it is difficult to grasp small objects by hand and increased precise function is required. Applications in which sterile forceps are commonly used include wound care: e.g. gripping, debridement procedures, removal of sutures, arrangement of dressing procedure pack contents, dressing wounds, including cavity wounds and removal of wound tissue.

    FDA Recall
    Open, Classified ·ConvaTec, Inc·Product code HTD·January 9, 2019

    Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3046

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code DYB·November 7, 2023

    Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3056

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code DYB·November 7, 2023

    Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-0053

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code DYB·November 7, 2023

    Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3052

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code DYB·November 7, 2023

    Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3015

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code DYB·November 7, 2023

    Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 Individual, and Part of Pump Set (005062, 0550-0008, 1000100, 0052-0011, 1000220)

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code DYB·November 7, 2023

    Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are intended to be inserted intermittently through the urethra and up to the bladder enabling urine to drain. They are designed for short-term, intermittent transient use only and are not intended to be left in situ (there is no balloon on the tip to allow the catheter to be retained within the bladder). They are intended for single use only. They are intended to be removed once the bladder is fully drained. The goal of intermittent catheterization using Urology Catheters is to completely empty the bladder and prevent Urinary Tract Infections (UTIs).

    FDA Recall
    Open, Classified ·ConvaTec, Inc·Product code KOD·January 9, 2019

    Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3014

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code DYB·November 7, 2023

    Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code DYB·November 7, 2023

    Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the body

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code DYB·November 7, 2023

    Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 2000342

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code DYB·November 7, 2023