BEUDAMED
    34 results · 26ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52

    FDA Enforcement
    Class II ·Terminated·LeMaitre Vascular, Inc.·March 22, 2017

    TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.

    FDA Enforcement
    Class II ·Terminated·Abeon Medical Corporation·January 27, 2016

    LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50

    FDA Enforcement
    Class II ·Terminated·LeMaitre Vascular, Inc.·March 22, 2017

    Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Revised Label: Product Label - Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 19-092400-041, USE BY: 2019-12-13, MFR DATE: 2019-10-14, CE 2797, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Package Label - DABRA 101 5 French, Ref: 1222-5000-01, Lot: LOT: 19-092400-041, USE BY: 2019-12-13, UDI's (01)00842362100031, (17)20191213(21)2019092400041

    FDA Enforcement
    Class II ·Terminated·Ra Medical Systems, Inc.·May 20, 2020

    TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.

    FDA Enforcement
    Class II ·Terminated·Abeon Medical Corporation·January 27, 2016

    LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52

    FDA Enforcement
    Class II ·Terminated·LeMaitre Vascular, Inc.·March 22, 2017

    LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52

    FDA Enforcement
    Class II ·Terminated·LeMaitre Vascular, Inc.·March 22, 2017

    LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53

    FDA Enforcement
    Class II ·Terminated·LeMaitre Vascular, Inc.·March 22, 2017

    Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800548002, Sterile, OR0637B - Extremity - Medical Center Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800557002, Sterile, LD0646B - C Section - Childrens Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800551003, Sterile, GS0640C - Lap Chole - Medical Center Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800553003, Sterile, OR0642C - Total Knee - Medical Center Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53

    FDA Enforcement
    Class II ·Terminated·LeMaitre Vascular, Inc.·March 22, 2017

    Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.

    FDA Enforcement
    Class II ·Terminated·Helena Laboratories, Corp.·October 9, 2019

    Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017