BEUDAMED
    38 results · 21ms · Sources: EU EUDAMED, US FDA

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    VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (4 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-988. Firm on the label: Boston Scientific.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DRE·March 5, 2004

    VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (5 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-994. Firm on the label: Boston Scientific.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DRE·March 5, 2004

    Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567

    FDA Recall
    Open, Classified ·Tobii Dynavox Llc·Product code ILQ·February 24, 2023

    Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code LLZ·January 3, 2024

    All Med Medical 20ga x 1" RA Hub Needle Model #M201H Reorder #55-2030 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.

    FDA Recall
    Terminated ·Multi-Med, Inc.·Product code FMI·August 30, 2010

    All Med Medical 22ga x 1" RA Hub Needle Model #M221H Reorder #55-2230 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.

    FDA Recall
    Terminated ·Multi-Med, Inc.·Product code FMI·August 30, 2010

    All Med Medical 19ga x 1" RA Hub Needle Model #M191H Reorder #55-1930 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.

    FDA Recall
    Terminated ·Multi-Med, Inc.·Product code FMI·August 30, 2010

    Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·March 12, 2020

    Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07

    FDA Recall
    Terminated ·New Era Orthopaedics, LLc·Product code MNI·February 13, 2017

    NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and irritated anterior or front of nasal passages caused by dry climate and indoor heat.

    FDA Recall
    Open, Classified ·Neilmed Pharmaceuticals Inc·Product code KCJ·December 28, 2024

    Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESCRIPTION M001271540 FLEXIMA BILIARY FIRM 8F/35CM M001271550 FLEXIMA BILIARY FIRM 10F/35CM M001271560 FLEXIMA BILIARY REG 8F/35CM M001271570 FLEXIMA BILIARY REG 10F/35CM M001271580 FLEXIMA BILIARY REG 12F/35CM M001271590 FLEXIMA BILIARY REG 14F/35CM M001271600 FLEXIMA BILIARY SOFT 10F/35CM M001271610 FLEXIMA BILIARY SOFT 12F/35CM M001271620 FLEXIMA BILIARY SOFT 14F/35CM M001281560 FLEXIMA BILIARY 8/35 TT M001281570 FLEXIMA BILIARY 10/35 TT M001281580 FLEXIMA BILIARY 12/35 TT M001281590 FLEXIMA BILIARY 14/35 TT M001271630 FLEXIMA BIL 8F/35CM FIRM KIT M001271640 FLEXIMA BIL 10F/35CM FIRM KIT M001271650 FLEXIMA BIL 8F/35CM REG KIT M001271660 FLEXIMA BIL 10F/35CM REG KIT Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FFA·March 18, 2009

    Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION 435428-01 M001273030 FLEXIMA VSCL REG 12FR/35CM M001273040 FLEXIMA VSCL REG 14FR/35CM M001273090 FLEXIMA VSDC REG LOOP 12/35KIT M001273100 FLEXIMA VSDC REG LOOP 14/35KIT M001273150 FLEXIMA VSCL FIRM 12FR/35CM M001273160 FLEXIMA VSCL FIRM 14FR/35CM M001273210 FLEXIMA VSDC FIRM LOOP 12/35 M001273220 FLEXIMA VSDC FIRM LOOP 14/35 Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FFA·March 18, 2009

    Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441. To facilitate transvenous introduction of diagnostic / therapeutic catheters into the vasculature and into the chambers of the heart.

    FDA Recall
    Terminated ·Greatbatch Medical·Product code DRA·September 6, 2012

    2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code ERA·May 9, 2025

    Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESCRIPTION M001271240 FLEXIMA APDL FIRM 10F/25CM M001271310 FLEXIMA APDL FIRM 6.3F/25CM M001271320 FLEXIMA APDL FIRM 8F/25CM M001271330 FLEXIMA APDL REG 6.3F/25CM M001271340 FLEXIMA APDL REG 8F/25CM M001271350 FLEXIMA APDL REG 10F/25CM M001271380 FLEXIMA APDL REG 12F/25CM M001271390 FLEXIMA APDL REG 14F/25CM M001271460 FLEXIMA QUICKSTICK LL 8FR M001271470 FLEXIMA QUICKSTICK LL 10FR M001275060 APDTL/7.3FR FLEXIMA SINGLE TT M001275080 APDLTL/7.3FR FLEXIMA SINGLE TT M001281340 FLEXIMA APDL 8/25 TT M001281350 FLEXIMA APDL 10/25 TT M001281380 FLEXIMA APDL 12/25 TT M001281390 FLEXIMA APDL 14/25 TT M001271960 FLEXIMA APDL 8FR REG KIT M001271970 FLEXIMA APDL 10FR REG KIT M001271980 FLEXIMA APDL 8FR FIRM KIT M001271990 FLEXIMA APDL 10FR FIRM KIT M001275070 APDTL/7.3FR FLEXIMA KIT TT M001275010 APDLTL/7.3 FLEXIMA FIRM SINGLE M001275090 APDLTL/7.3FR FLEXIMA KIT TT M001275030 FLEXIMA APDLTL/7/30 STAND KIT M001275050 FLEXIMA APDLTL/7/30 DELUXE KIT Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FFA·March 18, 2009

    Medtronic FlexCath, model 3FC12, Steerable Sheath. The FlexCath Steerable Sheath is a percutaneous catheter introducer fitted with a valve to allow for introduction, withdrawal, and swapping of catheters and wires while preventing air ingress and minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. Rx only. Sterilized using ethylene oxide. Manufacturer: Medtronic CryoCath LP, Kirkland, Quebec H9H 5H3, Canada. Product Usage: The FlexCath Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Management·Product code DRA·July 15, 2011

    Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code DRA·February 12, 2024

    VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code FFA·July 18, 2024

    Artisan Control Catheter, model number 04454, manufactured by Hansen Medical, Inc., Mountain View, CA. Steerable guide catheter for human use intended to facilitate manipulation, positioning and control for collecting electrophysiological data within the heart atria.

    FDA Recall
    Terminated ·Hansen Medical Inc·Product code DRA·May 21, 2008

    DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DRA·August 24, 2021