BEUDAMED
    63 results · 19ms · Sources: EU EUDAMED, US FDA

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    TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor)

    FDA Recall
    Terminated ·Radiometer America Inc·Product code KLK·February 2, 2005

    TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component)

    FDA Recall
    Terminated ·Radiometer America Inc·Product code KLK·April 7, 2006

    D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor)

    FDA Recall
    Terminated ·Radiometer America Inc·Product code KLK·November 1, 2005

    Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.

    FDA Enforcement
    Class II ·Terminated·Animas Corporation·November 5, 2014

    Ti-Magna Fx Washer Ti-Versa-FXII Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used with Ti-Versa-Fx II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna Fx System is an osteosynthesis item for orthopedic use in open internal fixation of fractures of the femoral neck, condyle, or tibia, etc. The washer prevents the screw head from being buried in the bone.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code NDG·August 28, 2013

    Liquid Alk Phos Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-L. In vitro diagnostic.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CJE·June 9, 2006

    Liquid Alk Phos R1 Reagent, Catalog No. 3-A7516-R1, In vitro diagnostic, Sold by Pointe Scientific.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CJE·February 7, 2008

    Liquid Alk Phos Reagent, Catalog No. 3-A7516-L, In vitro diagnostic, Sold by Pointe Scientific.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CJE·February 7, 2008

    Liquid Alk Phos R1 Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-R1. In vitro diagnostic.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CJE·June 9, 2006

    Liquid Alk Phos R2 Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-R2. In vitro diagnostic.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CJE·June 9, 2006

    Liquid Alk Phos R2 Reagent, Catalog No. 3-A7516-R2, In vitro diagnostic, Sold by Pointe Scientific

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CJE·February 7, 2008

    JUDKINS PACK

    FDA Recall
    Terminated ·Cardinal Health 200, LLC·Product code OEQ·February 11, 2021

    JUDKINS PACK

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·March 24, 2021

    Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent, Catalog Nos. 7-A7516-R1-120, 7-A7516-R1-500 and 8-A7516-R1-120, In vitro diagnostic, 50 mL, 120 mL , 2 L and 500 mL containers, Sold by Pointe Scientific.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CJE·February 7, 2008

    Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent; Catalog Nos. 7-A7516-R2-125, 7-A7516-R2-90 and 8-A7516-R2-30, In vitro diagnostic, 30 mL, 90 mL , 125 mL, and 400 mL containers, Sold by Pointe Scientific.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CJE·February 7, 2008

    Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent in 30 ml, 90 ml, 125 ml and 400 ml containers, sold by Pointe Scientific; Catalog nos. 7-A7516-R2-125, 7-A7516-R2-30, 7-A7516-R2-400ML, 7-A7516-R2-90, 8-A716-R2-125, 8-A7516-R2-30 and 8-A7516-R2-90. In vitro diagnostic.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CJE·June 9, 2006

    Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent in 50 ml, 120 ml, 2 L and 500 ml containers, sold by Pointe Scientific; Catalog nos. 7-HA716-R1-50-917, 7-A7516-R1-120, 7-A7516-R1-2L, 7-A7516-R1-500, 7-HA716-R1-500, 8-A7516-R1-120 and 8-A7516-R1-500. In vitro diagnostic.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CJE·June 9, 2006

    Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit containing reagent vials, Bio-Genex, San Ramon, CA.

    FDA Recall
    Terminated ·Biogenex Laboratories·Product code NJT·October 3, 2006

    Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·September 23, 2020

    Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2106388-103 Replacement ECG Leadwire, grabber, GRN RL, AHA, 130 cm/ 2106388-107 Replacement ECG Leadwire, grabber, BLK N, IEC, 130 cm/ 51 in 2106392-004 Replacement ECG Leadwire, grabber, ORG V, AHA, 74 cm/ 29 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.

    FDA Enforcement
    Class III ·Terminated·GE Healthcare, LLC·July 3, 2019