BEUDAMED
    22 results · 14ms · Sources: EU EUDAMED, US FDA

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    Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code N/A·July 17, 2019

    Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code N/A·July 17, 2019

    Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·August 28, 2019

    Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·August 28, 2019

    Hemospray Endoscopic Hemostat

    FDA Enforcement
    Class II ·Terminated·Wilson-Cook Medical Inc.·September 25, 2019

    DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.

    FDA Enforcement
    Class II ·Terminated·Derma Pen, LLC·September 16, 2015

    Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body parts with optimized PET technology.

    FDA Recall
    Terminated ·Naviscan PET Systems·Product code KPS·June 19, 2008

    PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging.

    FDA Recall
    Terminated ·Naviscan PET Systems·Product code KPS·August 1, 2007

    DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.

    FDA Recall
    Terminated ·Derma Pen, LLC·Product code PIU·February 5, 2015

    Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT

    FDA Recall
    Terminated ·Cti Pet Systems Inc·Product code KPS·October 2, 2003

    ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems: Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+, ECAT ART, ECAT EMERGE and ECAT ACCEL CTI Models: ECAT EXACT, ECAT EXACT HR+, ECAT ART, ECAT EMERGE, ECAT ACCEL, REVEAL QS and REVEAL XL Marconi Models: Magellan Hitachi Models: Sceptre and Sceptre XL

    FDA Recall
    Terminated ·Cti Pet Systems Inc·Product code KPS·March 4, 2003

    PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: Siemens Models: Biograph PET/CT CTI Models: Reveal PET/CT

    FDA Recall
    Terminated ·CTI PET Systems Inc·Product code KPS·May 27, 2004

    ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by CTI Molecular Imagining, Inc. Sceptre and Sceptre XL (mobile systems) distributed by Hitachi Medical Systems America

    FDA Recall
    Terminated ·CTI PET Systems Inc·Product code KPS·April 5, 2005

    Mammotome MammoStar Biopsy Site Identified, REF STAR1401

    FDA Recall
    Terminated ·Carbon Medical Technologies, Inc.·Product code NEU·December 16, 2022

    Medtronic One Source Pack Magellan, Catalog Number: COS310. Kits are packaging convenience kits containing previously released sterile-pack products and accessories. Medtronic Ideal MAXPAC Total System

    FDA Recall
    Terminated ·Medtronic Cardiovascular Revascularization & Surgical Therap·Product code OEU·March 23, 2009

    BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4313800 Rev. 1 01/11 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code NEU·January 23, 2013

    HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4

    FDA Recall
    Terminated ·Devicor Medical Products Inc·Product code NEU·March 30, 2022

    BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4320100 Rev. 0 03/10 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code NEU·January 23, 2013

    TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE

    FDA Recall
    Terminated ·Somatex Medical Technologies GmbH Rheinstr. 7 d Teltow Germany·Product code NEU·May 22, 2017

    Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003. One ring per plastic pouch, three rings are then placed into a plastic box with lid. This box is then placed into a solid white box. Item is shipped and sold non-sterile. It is intended to be used to radiographically (with X-Ray) mark the site of the "gastropexy" performed during gastric bypass surgery, thereby making it accessible for future diagnostic, therapeutic and feeding purposes.

    FDA Recall
    Terminated ·Kapp Surgical Instrument Inc·Product code NEU·May 24, 2011