BEUDAMED
    24 results · 12ms · Sources: EU EUDAMED, US FDA

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    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 27, 2019

    Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

    FDA Enforcement
    Class II ·Terminated·Medrad Inc·December 26, 2012

    Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·August 31, 2016

    Imager" II Angiographic Catheters, Sterilized with ethylene oxide gas, Manufactured for Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, USA, Made in Ireland, Unit 7,8 & 9 Annacotty Business Park, Annocotty, Co. Limerick, Ireland: Material Number (OUTER CARTON LABEL OF 5pk) /Material Number (INNER-POUCH LAB LE FOR EACH SINGLE CATHETER)/ Catalog Number /Material Description: M001314001 M001314000 31-400 IMAGER II/5/ST/65/038 BX5; M001314021 M001314020 31-402 IMAGER II/5/ST/65/035 BX 5; M001314071 M001314070 31-407 IMAGER II/5/BERN/40/035 BX 5; M001314081 M001314080 31-408 IMAGER II/5/BERN/40/038 BX5; M001314091 M001314090 31-409 IMAGER II/5/BERN/65/035 BX 5; M001314101 M001314100 31-410 IMAGER II/5/BERN/65/038 BX5; M001314301 M001314300 31-430 IMAGER II/5/SIM1/65/038 BX5; M001314521 M001314520 31-452 IMAGER II/5/CHGB/65/038 BX5; M001314561 M001314560 31-456 IMAGER II/5/CHG2.5/65/038 BX5; M001314571 M001314570 31-457 IMAGER II/5/CHG2.5/65/035 BX 5; M001314581 M001314580 31-458 IMAGER II/5/CONTRA 2/65/038 BX5; M001314591 M001314590 31-459 IMAGER II/5/CONTRA 2/65/035 BX 5; M001314611 M001314610 31-461 IMAGER II/5/DUCK/65/035 BX 5; M001314661 M001314660 31-466 IMAGER II/5/C2/65/038 BX5; M001314671 M001314670 31-467 IMAGER II/5/C2/65/035 BX 5; M001314681 M001314680 31-468 IMAGER II/5/C2+2 SIDE HOLES/65/038 BX5; M001314691 M001314690 31-469 IMAGER II/5/C2+2 SIDE HOLES/65/035 BX 5; M001314751 M001314750 31-475 IMAGER II/5/TRAIN/65/038 BX5; M001314761 M001314760 31-476 IMAGER II/5/MIK/65/038 BX5; M001314791 M001314790 31-479 IMAGER II/5/HK1.0/65/035 BX 5; M001314801 M001314800 31-480 IMAGER II/5/SHK0.8/65/038 BX5; M001314811 M001314810 31-481 IMAGER II/5/SHK0.8/65/035 BX 5; M001314821 M001314820 31-482 IMAGER II/5/SHK1.0/65/038 BX5; M001314851 M001314850 31-485 IMAGER II/5/RC1/65/035 BX 5; M001314861 M001314860 31-486 IMAGER II/5/RC2/65/038 BX5; M001314881 M001314880 31-488 IMAGER II/5/RDC/65/038 BX5; M001314891 M001314890 31-489 IMAGER II/5/RDC/65/035 BX 5 and M001314911 M001314910 31-49I IMAGER II/5/RDC+2 SIDEHOLES/65/035 BX 5: M001315001 M001315000 31-500 IMAGER II/4/TENNIS RACQUET/65/035 BX5; M001315031 M001315030 31-503 IMAGER II/5/TENNIS RACQUET/65/035 BX5; M001315061 M001315060 31-506 IMAGER II/5/TENNIS RACQUET/65/038 BX5; M001315091 M001315090 31-509 IMAGER II/4/PIGTAIL/65/035 BX5; M001315101 M001315100 31-510 IMAGER II/4/STRAIGHT/65/035 BX5; M001315131 M001315130 31-513 IMAGER II/5/PIGTAIL/65/038 BX5; M001315161 M001315160 31-516 IMAGER II/5/STAIGHT/65/038 BX5; M001315191 M001315190 31-519 IMAGER II/5/PIGTAIL/65/035 BX5; M001315201 M001315200 31-520 IMAGER II/5/STRAIGHT/65/035 BX5; M001315251 M001315250 31-525 IMAGER /4/CONTRALATERAL/65/035 BX5; M001315281 M001315280 31-528IMAGER II/5/CONTRALATERAL/65/035 BX5; M001315311 M001315310 31-531 IMAGER II/5/CONTRALATERAL/65/038 BX5; M001316021 M001316020 31-602 MODEL-IMAGER II/ 4/ ST/65/035; M001316071 M001316070 31-607 MODEL-IMAGER II/ 4/ BERN/40/035; M001316091 M001316090 31-609 MODEL-IMAGER II/ 4/ BERN/65/035; M001316311 M001316310 31-631 MODEL-IMAGER II/ 4/ SIM1/65/035; M001316531 M001316530 31-653 MODEL-IMAGER II/ 4/ CHGB/65/035; M001316551 M001316550 31-655 MODEL-IMAGER II/ 4/ CHGC/65/035; M001316581 M001316580 31-658 MODEL-IMAGER II/ 4/ CONTRA 2/65/035; M001316691 M001316690 31-669 MODEL-IMAGER II/4/C2+2 SIDE HOLES/65/035 and M001316851 M001316850 31-685 MODEL-IMAGER II/ 4/ RC1/65/035. Imager " II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters. These catheters are available in a variety of flush and selective shapes with

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQO·October 22, 2009

    Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·March 9, 2016

    Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·March 12, 2014

    M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS HOSP., Item No. 46068-02 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    Restoris MCK Onlay Insert Extractor.

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·June 13, 2018

    Microseal Master Cone Part Number: 815-9033 Microseal Master Cone is intended to obturate root canals during endodontic therapy procedures.

    FDA Recall
    Terminated ·Ormco Corporation·Product code EKM·September 9, 2010

    Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.

    FDA Recall
    Terminated ·Water Pik, Inc.·Product code JET·July 2, 2018

    Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand held button initiated injector device, and a soft seal nozzle affixed to the white injector. The product is sold individually in white, blue red and orange cartons with a photo of the device as well as a stream of water flowing through it. The contents of the container include the device as well as a package insert with utilization instructions. Product Usage: Sinus washing device to keep sinus passages clear of congestion.

    FDA Recall
    Terminated ·Water Pik, Inc.·Product code KMA·April 3, 2012

    RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·May 16, 2018

    Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.

    FDA Enforcement
    Class II ·Terminated·Water Pik, Inc.·August 15, 2018

    Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·November 15, 2017

    MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.

    FDA Enforcement
    Class III ·Terminated·Biomet, Inc.·June 17, 2015

    Mick TP Prostate Seeding Needles, 18 Gauge, Catalog/Model Number MTP-1820-C. --- BRAND NAME: Mick TP Disposable Needle 18 Gauge. COMMON/USUAL NAME: TP Needle 18 Gauge. CLASSIFICATION NAME: System, Applicator, Radionuclide, Manual. --- The needle is an accessory to the Mick 200-TPV Applicator and Kit. This one time use needle is used for brachytherapy. The product is sold in cartons with each carton containing a total of 25 needles. Each carton contains 4 packages of 5 needles, and 5 packages containing one needle each.

    FDA Recall
    Terminated ·Mick Radio Nuclear Instr Inc·Product code IWF·March 30, 2005

    M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS HOSP., Item No. 46068-02 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DRS·September 27, 2016

    Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code MDK·May 2, 2007

    iBOT 3000 Mobility System. Independence IBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device. The device is shipped one each per wooden pallet with wooden sides and top retained by reusable bands.

    FDA Recall
    Terminated ·Independence Technology LLC·Product code IMK·July 1, 2004

    Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820.

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code MDK·December 30, 2008