BEUDAMED
    21 results · 17ms · 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

    Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting.

    FDA Recall
    Terminated ·SEPPIM SAS ZONE INDUSTRIELLE SEES France·Product code CJY·September 4, 2013

    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

    Medtronic Ideal MAXPAC Total System, Catalog Numbers: TS1262R6, TS1262R7, TS1420R, TS1420R1, TS1442R, TS1446R, TS1464T, TS1470R, TS1470T1, TS1480R3, TS1480R5, TS1480R6, TS1487R, TS1487R2, TS8040R28, TS8108R6, TS8163R10, TS8387R5, TS9412R3, TS9453R28, TS9764R9, TS9800R28, TS9800R29, TS9800R31, TS9987R33 and TS9987R34. Sterile and nonpyrogenic, EtO or Gamma Sterilized. Medtronic Purfusion Systems. Kits are packaging convenience kits containing previously released sterile-pack products and accessories.

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

    Medtronic One Source Pack, Catalog Numbers: ATLS21, ATLS24, ATLS2469, EC1S24, EC2S00, EC2S24, EE1S048 and EE2S21. Kits are packaging convenience kits containing previously released sterile-pack products and accessories.

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

    ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL AUML-0250: URIC ACID MONO SL CHSL-0250: CHOLESTEROL SL, TGML-0250: TRIGLYCERIDES SL, CRSL-0250: CREATININE PAP SL HDLL-0230: CHOLESTEROL HDL SL 2G LDLL-0230: CHOLESTEROL LDL SL 2G

    FDA Recall
    Terminated ·ELITech Clinical Systems SAS Zone lndustrielle SEES France·Product code CGA·September 22, 2015

    Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (AUVD) Reference no. 77435- Triglycerides (TGML) Reference no. 77295- Cholesterol (CHVD) Reference no. 77301- Cholesterol HDL (HDLL) Reference no. 77310- Cholesterol, LDL (LDLL)

    FDA Recall
    Terminated ·ELITech Clinical Systems SAS Zone lndustrielle SEES France·Product code CGA·September 22, 2015

    Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, 55335 ENVOY 500 CREATININE REAGENT KIT 55301 ENVOY 500 HDL CHOLESTEROL REAGENT 55310 ENVOY 500 LDL CHOLESTEROL REAGENT KIT

    FDA Recall
    Terminated ·ELITech Clinical Systems SAS Zone lndustrielle SEES France·Product code CGA·September 22, 2015

    Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uric acid (AUVD) Reference no. 79435 Triglycerides (TGML) Reference no. 79295 Cholesterol (CHVD) Reference no. 79301 Cholesterol HDL (HDLL) Reference no. 79310 Cholesterol, LDL (LDLL)

    FDA Recall
    Terminated ·ELITech Clinical Systems SAS Zone lndustrielle SEES France·Product code CGA·September 22, 2015

    ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

    FDA Recall
    Terminated ·ELITech Clinical Systems SAS Zone lndustrielle SEES France·Product code CIT·August 11, 2014