BEUDAMED
    19 results · 10ms · Sources: EU EUDAMED, US FDA

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    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.

    FDA Enforcement
    Class II ·Terminated·Owen Mumford USA, Inc.·July 22, 2015

    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.

    FDA Recall
    Terminated ·Owen Mumford USA, Inc.·Product code FMF·December 11, 2014

    AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, Arrow AutoFuser Disposable Pain Control Pump

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·March 6, 2019

    Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Boston Scientific, IMAGER II Angiographic Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537. The following product is being recalled: "Material Number/(OUTER CARTON LABEL OF 5pk)"/"Material Number (INNER-POUCH LABEL FOR EACH SINGLE CATHETER)" / Material Description / Catalog Number. M001314001 M001314000 IMAGER II/5/ST/65/038 BX5 31-400 M001314011 M001314010 IMAGER II/5/ST/100/038 BX5 31-401 M001314021 M001314020 IMAGER II/5/ST/65/035 BX 5 31-402 M001314031 M001314030 IMAGER II/5/ST/100/035 BX 5 31-403 M001314041 M001314040 IMAGER II/5/BARNH/100/038 BX5 31-404 M001314051 M001314050 IMAGER II/5/BERN/100/038 BX5 31-405 M001314061 M001314060 IMAGER II/5/BERN/100/035 BX 5 31-406 M001314071 M001314070 IMAGER II/5/BERN/40/035 BX 5 31-407 M001314081 M001314080 IMAGER II/5/BERN/40/038 BX5 31-408 M001314091 M001314090 IMAGER II/5/BERN/65/035 BX 5 31-409 M001314101 M001314100 IMAGER II/5/BERN/65/038 BX5 31-410 M001314111 M001314110 IMAGER II/5/WEIN/100/038 BX5 31-411 M001314121 M001314120 IMAGER II/5/WEIN/100/035 BX 5 31-412 M001314131 M001314130 IMAGER II/5/H1/65/038 BX5 31-413 M001314141 M001314140 IMAGER II/5/H1/100/038 BX5 31-414 M001314151 M001314150 IMAGER II/5/H1/100/035 BX 5 31-415 M001314161 M001314160 IMAGER II/5/H3/100/038 BX5 31-416 M001314171 M001314170 IMAGER II/5/H3/100/035 BX 5 31-417 M001314181 M001314180 IMAGER II/5/H1H/100/038 BX5 31-418 M001314191 M001314190 IMAGER II/5/H1H/100/035 BX 5 31-419 M001314201 M001314200 IMAGER II/5/H3H/100/035 BX 5 31-420 M001314211 M001314210 IMAGER II/5/JB1/65/038 BX5 31-421 M001314221 M001314220 IMAGER II/5/JB1/100/038 BX5 31-422 M001314231 M001314230 IMAGER II/5/JB1/100/035 BX 5 31-423 M001314241 M001314240 IMAGER II/5/JB2/100/038 BX5 31-424 M001314251 M001314250 IMAGER II/5/JB2/100/035 BX 5 31-425 M001314261 M001314260 IMAGER II/5/JB3/100/038 BX5 31-426 M001314271 M001314270 IMAGER II/5/JB3/100/035 BX 5 31-427 M001314281 M001314280 IMAGER II/5/MAN/100/038 BX5 31-428 M001314291 M001314290 IMAGER II/5/MAN/100/035 BX 5 31-429 M001314301 M001314300 IMAGER II/5/SIM1/65/038 BX5 31-430 M001314311 M001314310 IMAGER II/5/SIM1/65/035 BX 5 31-431 M001314321 M001314320 IMAGER II/5/SIM1/100/038 BX5 31-432 M001314331 M001314330 IMAGER II/5/SIM1/100/035 BX 5 31-433 M001314341 M001314340 IMAGER II/5/SIM2/100/038 BX5 31-434 M001314351 M001314350 IMAGER II/5/SIM2/100/035 BX 5 31-435 M001314361 M001314360 IMAGER II/5/SIM3/100/038 BX5 31-436 M001314371 M001314370 IMAGER II/5/SIM3/100/035 BX 5 31-437 M001314381 M001314380 IMAGER II/5/SIM4/100/038 BX5 31-438 M001314391 M001314390 IMAGER II/5/HN1/100/038 BX5 31-439 M001314401 M001314400 IMAGER II/5/HN1/100/035 BX 5 31-440 M001314411 M001314410 IMAGER II/5/HN2/100/038 BX5 31-441 M001314421 M001314420 IMAGER II/5/HN2/100/035 BX 5 31-442 M001314431 M001314430 IMAGER II/5/HN3/100/038 BX5 31-443 M001314441 M001314440 IMAGER II/5/HN3/100/035 BX 5 31-444 M001314451 M001314450 IMAGER II/5/HN4/100/038 BX5 31-445 M001314461 M001314460 IMAGER II/5/HN4/100/035 BX 5 31-446 M001314471 M001314470 IMAGER II/5/HN5/100/038 BX5 31-447 M001314481 M001314480 IMAGER II/5/HN5/100/035 BX 5 31-448 M001314491 M001314490 IMAGER II/5/CK/100/035 BX 5 31-449 M001314501 M001314500 IMAGER II/5/GEN/100/035 BX 5 31-450 M001314511 M001314510 IMAGER II/5/GEN+2 SIDEHOLES/100/035 BX 5 31-451 M001314521 M001314520 IMAGER II/5/CHGB/65/038 BX5 31-452 M001314531 M001314530 IMAGER II/5/CHGB/65/035 BX 5 31-453 M001314541 M001314540 IMAGER II/5/CHGC/65/038 BX5 31-454 M001314551 M001314550 IMAGER II/5/CHGC/65/035 BX 5 31-455 M001314561 M001314560 IMAGER II/5/CHG2.5/65/038 BX5 31-456 M001314571 M001314570 IMAGER II/5/CHG2.5/65/035 BX 5 31-457 M001314581 M001314580 IMAGER II/5/CONTRA 2/65/038 BX5 31-458 M001314591 M001314590 IMAGER II/5/CONTRA 2/65/035 BX 5 31-459 M001314611 M001314610 IMAGER II/5/DUCK/65/035 BX 5 31-4

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQO·March 15, 2012

    VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US Distribution/Manufactured for GYNECARE, A division of Ethicon, Inc., a Johnson & Johnson Company, Somerville, NJ 08876. The product subject of this recall is the connector cable which goes between the electrosurgical generator and the elctrode used for surgery. Specifically, the recall focuses on the hand grip on the electrode, formed by overmolding a polymer onto the cable, which deforms upon sterilization.

    FDA Recall
    Terminated ·Ethicon, Inc US·Product code HIH·December 16, 2004

    E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology.

    FDA Recall
    Terminated ·Richard Wolf Medical Instruments Corp.·Product code HIH·May 23, 2019

    PENTRA 120 and PENTRA 120 Retic Hematology Analyzer

    FDA Recall
    Terminated ·ABX Diagnostics Inc·Product code GJH·June 24, 2004

    CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HIH·April 9, 2020

    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.

    FDA Recall
    Terminated ·Mizuho America, Inc.·Product code HCH·October 10, 2013

    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.

    FDA Recall
    Terminated ·Mizuho America, Inc.·Product code HCH·October 10, 2013

    ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee System. The cannula contains a light source and a camera at the distal end, which can be used for live visualization. The camera can also capture video and images of the diagnostic area for later diagnostic analysis. The Advanced Endosee Cannulas (P/N: ESPX5) are sold in boxes of 5 units/box. Quantities presented are by box.

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HIH·December 13, 2019