BEUDAMED
    11 results · 7ms · Sources: EU EUDAMED, US FDA

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    Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL LINE PREPARATION PACK DT10415 PICC INSERTION TRAY DT10495 PICC INSERTION TRAY DT10525 CENTRAL LINE INSERTION DRAPE KIT DT10675 CENTRAL LINE INSERTION PROCEDURE KIT DT10755 DRESS UP KIT DT10850 PORT DRESSING CHANGE TRAY DT10850 PORT DRESSING CHANGE TRAY DT11300 DIALYSIS ON/OFF KIT DT11610 DRESSING CHANGE TRAY DT11955 UNIVERSAL LINE FULL BODY DRAPE KIT - REG DT12220 CVC DRESSING CHANGE TRAY DT12270 DRESSING CHANGE TRAY DT12270 DRESSING CHANGE TRAY DT12415 NEONATAL PICC INSERTION TRAY DT12415 NEONATAL PICC INSERTION TRAY DT12485 PEDI CENT LINE TRAY W/SORB SHIELD DT12540 CENTRAL LINE PACK DT12555 UNIVERSAL CVC INS SUPP TRAY DT12725 CENTRAL LINE DRESSING TRAY DT12900 CL / PICC DRESSING CHANGE TRAY DT13005A CVC DRESSING CHANGE TRAY DT13055 PICC/CENTRAL LINE DRESSING CHANGE DT13055 PICC/CENTRAL LINE DRESSING CHANGE DT13055 PICC/CENTRAL LINE DRESSING CHANGE DT13125 CENTRAL LINE TRAY DT13525 DRESSING CHANGE TRAY DT13560 PORT ACCESS TRAY DT13560 PORT ACCESS TRAY DT13560 PORT ACCESS TRAY DT13635 DRESSING CHANGE TRAY DT13725 ON/OFF KITS DT13835 DRESSING CHANGE TRAY W/BIOPATCH DT13885 DRESSING CHANGE TRAY DT14065 CVC KIT DT14100 CENTRAL LINE DSG CHG TRAY W/BIOPATCH DT14135 PICC/CVC DRSG CHNG TRAY W/SORB SHIELD DT14180 UNIVERSAL CATHETER INSERTION SET DT14215 CVC LINE DRESSING CHANGE DT14215 CVC LINE DRESSING CHANGE DT14380 PICC MAINTENANCE PACK DT14470 CVC DRSG CH W/BIOPATCH & SORB SHLD DT14500 CENTRAL LINE DRESSING CHANGE TRAY DT14500 CENTRAL LINE DRESSING CHANGE TRAY DT14500 CENTRAL LINE DRESSING CHANGE TRAY DT14650 MAXIMUM PROTECTION KIT DT14865 PORT CATH FLUSH KIT DT14965 PROCEDURE KIT DT15160 ADULT PORT FLUSH KIT DT15370 IN-PATIENT VAD KIT DT15370 IN-PATIENT VAD KIT DT15600 DRESSING CHANGE TRAY DT15605A CVC DRESSING CHANGE TRAY DT15655 CVC INSERTION TRAY DT15775 NICU PICC LINE DRESSING CHANGE KIT DT15780A PORT AND IO ACCESS DRESSING KIT DT15970 MAXIMUM PROTECTION KIT DT15970 MAXIMUM PROTECTION KIT DT15975 CENTRAL LINE INSERTION KIT DT15995 BOND CLINIC PORT DRESSING TRAY DT16435 CENTRAL LINE DRESSING KIT DT16480 PICC CENTRAL CVC CHANGE TRAY DT16550 ICU ARTERIAL LINE TRAY DT16550 ICU ARTERIAL LINE TRAY DT17055 CENTRAL LINE ACCESSORY PACK DT17120 VAD ACCESS KIT DT17135 NEONATAL DRESSING CHANGE TRAY DT17265 SUBC/PICC DRESS TRAY W/4MM BIOPATCH DT17365 SINGLE PORT ACCESS TRAY DT17380 IJ VAS-CATH DRESSING CHANGE TRAY DT17410 ON/OFF KIT & DRESSING CHANGE TRAY DT17420 ACCESS PORT KIT DT17500 PICC DRESSING KIT DT17675 DRIVELINE MANAGEMENT SYSTEM W/O BIOPATCH DT17745 DRESSING CHANGE TRAY DT17850 PORT DRESSING TRAY WITH BIOPATCH DT17870 WEEKLY DRIVELINE MANAGEMENT SYSTEM DT17965 PORT ACCESS TRAY DT18030 PORT ACCESS TRAY DT18375 DRIVELINE MANAGEMENT SYSTEM (W) DT18395 PORT ACCESS TRAY DT18415 PORT DRESSING CHANGE TRAY DT18450 PORT ACCESS DRESSING CHANGE TRAY DT18545 PORT DRESSING CHANGE TRAY DT18600 DRIVELINE MANAGEMENT SYSTEM w/CHG DT18600 DRIVELINE MANAGEMENT SYSTEM w/CHG DT18655 DAILY LVAD DRESSING KIT DT18675 LVAD MANAGEMENT SYSTEM-WEEKLY DT18690 DRIVELINE MANAGEMENT SYSTEM DT18690 DRIVELINE MANAGEMENT SYSTEM DT18695A DRIVELINE MGMT. KIT WITH SILVER ALGINATE DT18775 PORT ACCESS TRAY DT19625 PORT ACCESS TRAY DT19665 CENTRAL LINE DRESSING CHANGE KIT DT19665 CENTRAL LINE DRESSING CHANGE KIT DT19820 PEDIATRIC DRESSING CHANGE TRAY DT19835A PEDIATRIC PORT ACCESS BUNDLE DT19840 PORT ACCESS TRAY DT19900 CENTRAL LINE DRESSING CHANGE OVAL SHIELD DT20060 PORT ACCESS KIT DT20100 PORT ACCESS TRAY W/SECUREVIEW DT20160 PORT ACCESS KIT DT20335 KAISER CENTRAL LINE MANAGEMENT SYSTEM DT20335 KAISER CENTRAL LINE MANAGEMENT SYSTEM DT20350A DIALYSIS OFF KIT DT20370A CVC/PORT ACCESS TRAY DT20385 CENTRAL LINE DRESSING KIT DT20405 PICU MAX BARRIER KIT DT20480 PICC AND PORT DRESSING KIT DT20570 CENTRAL LINE CARE & MAINTENANCE BUNDLE DT20640 PORT DRESSING CHANGE TRAY DT20

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·February 12, 2020

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SpA·November 4, 2015

    MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SPA·August 9, 2017

    Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SpA·October 2, 2019

    MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SpA·October 2, 2019

    IRON assay, Reference Numbers 6K95-41 and 6K95-30

    FDA Enforcement
    Class II ·Ongoing·Sentinel CH SpA·November 29, 2023

    Alinity c Iron Reagent, Reference Number 08P3920

    FDA Enforcement
    Class II ·Ongoing·Sentinel CH SpA·November 29, 2023

    GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold under the following product names: CT GOLDSEAL LIGHTSPEED ULTRA, CT OPTIMA 660, CT OPTIMA 660 M40 3.5 LONG BJG, CT OPTIMA 660 M40 GT1700, CT OPTIMA 660 M40 GT1700 BEIJI, CT OPTIMA 660 M40 GT1700 HINO, CT OPTIMA 660 M40 GT2000 BEIJI, CT OPTIMA 660 M40 GT2000 HINO, CT OPTIMA CT 660, CT OPTIMA CT660, CT OPTIMA CT660 M4, CT OPTIMA CT660 M40, CT REVOLUTION EVO 3.5 LONG HIN, CT REVOLUTION EVO VT2000 HINO, CT660 MAR UPGRADE, MOBILE OPTIMA CT 660, OPTI660_A_G_2.0, OPTI660_M40_G, OPTI660_M40_L, OPTIMA 660, OPTIMA 660 128 FOR TW- DIRECT, OPTIMA 660 GT2000 M40 HINO MULTISLICE, OPTIMA 660 M40, OPTIMA 660 M40, OPTIMA 660 M40 3.5 HVY BJG, OPTIMA 660 M40 3.5 LONG BJG, OPTIMA 660 M40 3.5 LONG BJG, OPTIMA 660 M40 3.5 LONG HINO, OPTIMA 660 M40 3.5 MID, OPTIMA 660 M40 3.5 MID BJG, OPTIMA 660 M40 3.5 MID HINO, OPTIMA 660 M40 3.5/6, OPTIMA 660 M40 3.5/6 HVY BJG, OPTIMA 660 M40 3.5/6 HVY HINO, OPTIMA 660 M40 3.5/6 HVY WAUK, OPTIMA 660 M40 3.5/6 LONG, OPTIMA 660 M40 3.5/6 LONG B, OPTIMA 660 M40 3.5/6 LONG BJG, OPTIMA 660 M40 3.5/6 LONG HINO, OPTIMA 660 M40 3.5/6 LONG WAUK, OPTIMA 660 M40 3.5/6 MID BJ, OPTIMA 660 M40 3.5/6 MID BJG, OPTIMA 660 M40 3.5/6 MID HI, OPTIMA 660 M40 3.5/6 MID HINO, OPTIMA 660 M40 3.5/6 MID WA, OPTIMA 660 M40 3.5/6 MID WAUK, OPTIMA 660 M40 GT1700, OPTIMA 660 M40 GT1700 BEIJING, OPTIMA 660 M40 GT1700 HINO, OPTIMA 660 M40 GT1700 WAUK, OPTIMA 660 M40 GT2000 B, OPTIMA 660 M40 GT2000 BEIJI, OPTIMA 660 M40 GT2000 BEIJING, OPTIMA 660 M40 GT2000 HINO, OPTIMA 660 M40 GT2000 WAUK, OPTIMA 660 M40 MOBILE BEIJING, OPTIMA CT 660, OPTIMA CT660 ASIR, OPTIMA CT660 ASIR 128 M RU, OPTIMA CT660 FREEDOM MD HN2, OPTIMA CT660 M40 GT1700, OPTIMA CT660 M40 GT2000, OPTIMA CT660 M40 GT2000 BEIJIN, OPTIMA CT660 M40 GT2000 HINO, OPTIMA CT660 P2.5, OPTIMA CT660 P25 UPG KIT, OPTIMA CT660 PRO MID, OPTIMA CT660 SE, OPTIMA CT660 SE GT 1700, OPTIMA CT680, OPTIMA CT680 KL64 GT1700 BHW, REVOLUTION EVO, REVOLUTION EVO 3.5 HVY BJG, REVOLUTION EVO 3.5 HVY HINO, REVOLUTION EVO 3.5 HVY WAUK, REVOLUTION EVO 3.5 LONG BJG, REVOLUTION EVO 3.5 LONG HINO, REVOLUTION EVO 3.5 LONG WAUK, REVOLUTION EVO 3.5 MID BJG, REVOLUTION EVO 3.5 MID HINO, REVOLUTION EVO 3.5 MID WAUK, REVOLUTION EVO 3.5MID HINO CT, REVOLUTION EVO 3.6 CHN HINO, REVOLUTION EVO 3.6 HVY BJG, REVOLUTION EVO 3.6 HVY HINO, REVOLUTION EVO 3.6 HVY WAUK, REVOLUTION EVO 3.6 LONG, REVOLUTION EVO 3.6 LONG BJG, REVOLUTION EVO 3.6 LONG HIN, REVOLUTION EVO 3.6 LONG HINO, REVOLUTION EVO 3.6 LONG WAUK, REVOLUTION EVO 3.6 MID BJG, REVOLUTION EVO 3.6 MID HINO, REVOLUTION EVO 3.6 MID WAUK, REVOLUTION EVO 3.6B, REVOLUTION EVO 3.6B HVY HINO, REVOLUTION EVO 3.6B LONG, REVOLUTION EVO 3.6B LONG BJG, REVOLUTION EVO 3.6B LONG HINO, REVOLUTION EVO 3.6B MID BJG, REVOLUTION EVO 3.6B MID HINO, REVOLUTION EVO GT1700, REVOLUTION EVO GT2000, REVOLUTION EVO GT2000 HINO, REVOLUTION EVO GT2000X (HINO), REVOLUTION EVO GT2000X HINO, REVOLUTION EVO VT1700 BEIJING, REVOLUTION EVO VT1700 HINO, REVOLUTION EVO VT1700 WAUK, REVOLUTION EVO VT2000 BEIJING, REVOLUTION EVO VT2000 HINO, REVOLUTION EVO VT2000 WAUK, REVOLUTION EVO VT2000X BEIJING, REVOLUTION EVO VT2000X HINO, REVOLUTION EVO VT2000X WAUK, REVOLUTION EVO WITH GT1700V TA, REVOLUTION EVO WITH GT2000 TAB

    FDA Enforcement
    Class II ·Terminated·GE Healthcare Japan Corporation·August 29, 2018