BEUDAMED
    24 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room.

    FDA Enforcement
    Class II ·Terminated·CareFusion Corporation·April 3, 2013

    PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·October 6, 2021

    PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·October 6, 2021

    BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·November 6, 2019

    Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter for use with Intravenous Administration Sets

    FDA Enforcement
    Class II ·Terminated·Bayer Medical Care, Inc.·October 17, 2018

    SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V. Label on box: SpermMar Test IGA 50 Determination Test Kit CONTENTS 1 vial SpermMar Latex Particles 0.7 ml REF SPMA_S FertiPro FertiPro N.V. Label on box: SpermMar Test IgA 50 Determination Test Kit Contents: 1 vial SpermMar latex particles, 0.7ml FertiPro N.V. For In Vitro Diagnostic Use SpermMar IqA Test Manufacturer's Product Number/Catalog Number: SPMA_S Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016 Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information.

    FDA Enforcement
    Class II ·Terminated·Vitrolife Inc·April 22, 2015

    Product 59 consists of all product under product code: JWH and same usage: Item no: 42540000026 PSN ALL POLY PAT PLY 26MM 42540000029 PSN ALL POLY PAT PLY 29MM 42540000032 PSN ALL POLY PAT PLY 32MM 42540000035 PSN ALL POLY PAT PLY 35MM 42540000038 PSN ALL POLY PAT PLY 38MM 42540000041 PSN ALL POLY PAT PLY 41MM 42511000510 PSN ASF CR 10MM PLY L 3-1 42511000410 PSN ASF CR 10MM PLY L 3-9 42511000610 PSN ASF CR 10MM PLY L 7-1 42521000510 PSN ASF CR 10MM PLY R 3-1 42521000410 PSN ASF CR 10MM PLY R 3-9 42521000610 PSN ASF CR 10MM PLY R 7-1 42511000511 PSN ASF CR 11MM PLY L 3-1 42511000411 PSN ASF CR 11MM PLY L 3-9 42511000611 PSN ASF CR 11MM PLY L 7-1 42521000511 PSN ASF CR 11MM PLY R 3-1 42521000411 PSN ASF CR 11MM PLY R 3-9 42521000611 PSN ASF CR 11MM PLY R 7-1 42511000512 PSN ASF CR 12MM PLY L 3-1 42511000412 PSN ASF CR 12MM PLY L 3-9 42511000612 PSN ASF CR 12MM PLY L 7-1 42521000512 PSN ASF CR 12MM PLY R 3-1 42521000412 PSN ASF CR 12MM PLY R 3-9 42521000612 PSN ASF CR 12MM PLY R 7-1 42511000513 PSN ASF CR 13MM PLY L 3-1 42511000413 PSN ASF CR 13MM PLY L 3-9 42511000613 PSN ASF CR 13MM PLY L 7-1 42521000513 PSN ASF CR 13MM PLY R 3-1 42521000413 PSN ASF CR 13MM PLY R 3-9 42521000613 PSN ASF CR 13MM PLY R 7-1 42511000514 PSN ASF CR 14MM PLY L 3-1 42511000414 PSN ASF CR 14MM PLY L 3-9 42511000614 PSN ASF CR 14MM PLY L 7-1 42521000514 PSN ASF CR 14MM PLY R 3-1 42521000414 PSN ASF CR 14MM PLY R 3-9 42521000614 PSN ASF CR 14MM PLY R 7-1 42511000516 PSN ASF CR 16MM PLY L 3-1 42511000416 PSN ASF CR 16MM PLY L 3-9 42511000616 PSN ASF CR 16MM PLY L 7-1 42521000516 PSN ASF CR 16MM PLY R 3-1 42521000416 PSN ASF CR 16MM PLY R 3-9 42521000616 PSN ASF CR 16MM PLY R 7-1 42511000518 PSN ASF CR 18MM PLY L 3-1 42511000418 PSN ASF CR 18MM PLY L 3-9 42511000618 PSN ASF CR 18MM PLY L 7-1 42521000518 PSN ASF CR 18MM PLY R 3-1 42521000418 PSN ASF CR 18MM PLY R 3-9 42521000618 PSN ASF CR 18MM PLY R 7-1 42511400810 PSN ASF PS 10MM PLY L 10- 42511401010 PSN ASF PS 10MM PLY L 10- 42511400410 PSN ASF PS 10MM PLY L 3-5 42511400610 PSN ASF PS 10MM PLY L 3-5 42511400510 PSN ASF PS 10MM PLY L 6-9 42511400710 PSN ASF PS 10MM PLY L 6-9 42511400910 PSN ASF PS 10MM PLY L 6-9 42521400810 PSN ASF PS 10MM PLY R 10- 42521401010 PSN ASF PS 10MM PLY R 10- 42521400410 PSN ASF PS 10MM PLY R 3-5 42521400610 PSN ASF PS 10MM PLY R 3-5 42521400510 PSN ASF PS 10MM PLY R 6-9 42521400710 PSN ASF PS 10MM PLY R 6-9 42521400910 PSN ASF PS 10MM PLY R 6-9 42511400811 PSN ASF PS 11MM PLY L 10- 42511401011 PSN ASF PS 11MM PLY L 10- 42511400411 PSN ASF PS 11MM PLY L 3-5 42511400611 PSN ASF PS 11MM PLY L 3-5 42511400511 PSN ASF PS 11MM PLY L 6-9 42511400711 PSN ASF PS 11MM PLY L 6-9 42511400911 PSN ASF PS 11MM PLY L 6-9 42521400811 PSN ASF PS 11MM PLY R 10- 42521401011 PSN ASF PS 11MM PLY R 10- 42521400411 PSN ASF PS 11MM PLY R 3-5 42521400611 PSN ASF PS 11MM PLY R 3-5 42521400511 PSN ASF PS 11MM PLY R 6-9 42521400711 PSN ASF PS 11MM PLY R 6-9 42521400911 PSN ASF PS 11MM PLY R 6-9 42511400812 PSN ASF PS 12MM PLY L 10- 42511401012 PSN ASF PS 12MM PLY L 10- 42511400412 PSN ASF PS 12MM PLY L 3-5 42511400612 PSN ASF PS 12MM PLY L 3-5 42511400512 PSN ASF PS 12MM PLY L 6-9 42511400712 PSN ASF PS 12MM PLY L 6-9 42511400912 PSN ASF PS 12MM PLY L 6-9 42521400812 PSN ASF PS 12MM PLY R 10- 42521401012 PSN ASF PS 12MM PLY R 10- 42521400412 PSN ASF PS 12MM PLY R 3-5 42521400612 PSN ASF PS 12MM PLY R 3-5 42521400512 PSN ASF PS 12MM PLY R 6-9 42521400712 PSN ASF PS 12MM PLY R 6-9 42521400912 PSN ASF PS 12MM PLY R 6-9 42511400813 PSN ASF PS 13MM PLY L 10- 42511401013 PSN ASF PS 13MM PLY L 10- 42511400413 PSN ASF PS 13MM PLY L 3-5 42511400613 PSN ASF PS 13MM PLY L 3-5 42511400513 PSN ASF PS 13MM PLY L 6-9 42511400713 PSN ASF PS 13MM PLY L 6-9 42511400913 PSN ASF PS 13MM PLY L 6-9 42521400813 PSN ASF PS 13MM PLY R 10- 42521401013 PSN ASF PS 13MM PLY R 10- 42521400413 PSN ASF PS 13MM PLY R 3-5 42521400613 P

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    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

    Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical procedures. This patented Transcollation technology has been shown to reduce transfusion rates and may also reduce the need for other blood management procedures.

    FDA Enforcement
    Class II ·Terminated·Medtronic Advanced Energy, LLC·February 12, 2014

    PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.

    FDA Enforcement
    Class II ·Terminated·Zimmer CAS·December 10, 2014

    Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;

    FDA Enforcement
    Class II ·Terminated·Zimmer CAS·June 10, 2015

    Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs

    FDA Enforcement
    Class II ·Terminated·Church & Dwight Inc·July 31, 2013

    Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.

    FDA Enforcement
    Class II ·Terminated·JAS Diagnostics Inc.·December 24, 2014

    Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.

    FDA Enforcement
    Class II ·Terminated·JAS Diagnostics Inc.·July 2, 2014

    Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.

    FDA Enforcement
    Class II ·Terminated·JAS Diagnostics Inc.·July 12, 2017

    Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.

    FDA Enforcement
    Class II ·Terminated·Jas Diagnostics/Drew Scientific·May 4, 2016

    Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·August 28, 2013

    On Site Gas Systems POGS 33C Portable Oxygen Generation System

    FDA Enforcement
    Class II ·Terminated·On Site Gas Systems Inc.·January 15, 2014

    MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.

    FDA Enforcement
    Class II ·Terminated·Linde Gas North America Llc·June 26, 2013

    SmartTools Knee System Orthopedic Stereotaxic Instrument

    FDA Enforcement
    Class II ·Terminated·Orthosoft, Inc. dba Zimmer CAS·April 26, 2017