BEUDAMED
    19 results · 16ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii ×

    Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, Lp·August 7, 2019

    FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip.

    FDA Enforcement
    Class II ·Terminated·Djo Surgical·March 12, 2014

    BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 155140-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 155142-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 155143-01 BD PYXIS MEDBANK TWR MN CR-14HH-P / 155144-01 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM / 155145-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P / 155156-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P / 155157-01 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P / 155151-01 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P / 155152-01 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P / 155153-01 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P / 155154-01 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P / 155155-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FH / 155146-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FM / 155147-01 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P / 155148-01 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P / 155149-01 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P / 155150-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P / 169-114 BD PYXIS MEDBANK MINI CR-4HH-P / 169-115 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 169-82 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 169-83 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 169-84 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 169-85 BD PYXIS MEDBANK TWR MN CR-14HH-P / 169-86 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM / 169-87 BD PYXIS MEDBANK TWR MN CR-2HH-6FH / 169-88 BD PYXIS MEDBANK TWR MN CR-2HH-6FM / 169-89 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P / 169-90 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P / 169-91 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P / 169-92 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P /169-93 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P / 169-94 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P / 169-95 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P / 169-96 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P / 169-97 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P / 169-98 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P / 169-99 BD PYXIS MEDBANK MINI CR-2HH-1FH-P / 138913-01 BD PYXIS MEDBANK MINI CR-4HH-P / 138911-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P / 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P / 139002-01 BD PYXIS MEDBANK MN 200 CR-4HH-P / 139000-01 BD PYXIS MEDBANK MN 500 CR-2HH-1FM-2DD-P / 139020-01 BD PYXIS MEDBANK MN 500 CR-2HH-5FM-P / 139018-01 BD PYXIS MEDBANK MN 500 CR-4HH-1FH-3FM-P / 139019-01 BD PYXIS MEDBANK MN 500 CR-4HH-4FM-P / 139021-01 BD PYXIS MEDBANK MN 500 CR-6HH-3FM-P / 139022-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 138973-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 138975-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 139073-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 138976-01 BD PYXIS MEDBANK TWR MN CR-14HH-P / 138977-01 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM / 138951-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FH / 139072-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FM / 139085-01 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P / 138968-01 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P / 138964-01 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P / 138966-01 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P /138967-01 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P / 138969-01 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P / 138965-01 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P / 138971-01 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P / 138972-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P / 138974-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P / 138970-01 BD Pyxis QFill Replenishment Station / 138904-01 KIT BD PYXIS QFILL REPLENISHMENT STATION / 155197-01 MEDBANK UPOS211 AIO WIN10 QFILL 1.5 / 155215-05 OPT,MEDBANK,HD,WIN10,QFILL,CR / 131944-04 The BD Pyxis" MedBank" CUBIE" Replenishment Station is an Automated Dispensing Cabinet (ADC) that is intended to be used by a qualified and authorized user to replenish medications and supplies to a BD Pyxis" MedBank" cabinet.

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·April 16, 2025

    PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP

    FDA Enforcement
    Class II ·Ongoing·Ethicon Endo Surgery, LLC·April 9, 2025

    BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·August 14, 2024

    BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·August 14, 2024

    138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P 139002-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P 139000-01 BD PYXIS MEDBANK MN 200 CR-4HH-P 139020-01 BD PYXIS MEDBANK MN 500 CR-2HH-1FM-2DD-P 139018-01 BD PYXIS MEDBANK MN 500 CR-2HH-5FM-P 139019-01 BD PYXIS MEDBANK MN 500 CR-4HH-1FH-3FM-P 139021-01 BD PYXIS MEDBANK MN 500 CR-4HH-4FM-P 139022-01 BD PYXIS MEDBANK MN 500 CR-6HH-3FM-P 138973-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 155140-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 169-82 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 138975-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 169-83 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 139073-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH 155142-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH 169-84 BD PYXIS MEDBANK TWR MN CR-12HH-1FH 138976-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 155143-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 169-85 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 138977-01 BD PYXIS MEDBANK TWR MN CR-14HH-P 155144-01 BD PYXIS MEDBANK TWR MN CR-14HH-P 169-86 BD PYXIS MEDBANK TWR MN CR-14HH-P 138951-01 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 155145-01 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 169-87 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 139072-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FH 155146-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FH 169-88 BD PYXIS MEDBANK TWR MN CR-2HH-6FH 139085-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FM 155147-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FM 169-89 BD PYXIS MEDBANK TWR MN CR-2HH-6FM 138968-01 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 155148-01 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 169-90 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 138964-01 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 155149-01 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 169-91 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 138966-01 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 155150-01 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 169-92 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 138967-01 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 155151-01 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 169-93 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 138969-01 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 155152-01 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 169-94 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 138965-01 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 155153-01 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 169-95 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 138971-01 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 155154-01 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 169-96 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 138972-01 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 155155-01 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 169-97 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 138974-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 155156-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 169-98 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 138970-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P 155157-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P 169-99 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·March 5, 2025

    IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325 cc), Part No. 3748 3) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, 1 Quart (946 cc), P/N 3306 4) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid PN 7450, 5) ThermoFlex ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS 1 Quart (946 cc) P/N 7465 Indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base

    FDA Enforcement
    Class II ·Terminated·CMP Industries, Llc·July 6, 2016

    IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface

    FDA Enforcement
    Class II ·Terminated·CMP Industries, Llc·July 6, 2016

    IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML), REF 3748, Rx ONLY, 3) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid, PN 7450; Indicated for relining a denture surface.

    FDA Enforcement
    Class II ·Terminated·CMP Industries, Llc·July 6, 2016

    IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. Indicated for relining a denture surface for repairing a fractured denture, or forming a new denture base.

    FDA Enforcement
    Class II ·Terminated·CMP Industries, Llc·March 16, 2016

    IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards

    FDA Enforcement
    Class II ·Terminated·CMP Industries, Llc·November 7, 2018

    Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF: 3748GB. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards

    FDA Enforcement
    Class II ·Terminated·CMP Industries, Llc·November 7, 2018

    139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2HH-1FM MEDPASS 169-150 BD PYXIS MEDBANK MINI 4HH MEDPASS 169-140 BD PYXIS MEDBANK TWR MN 3FH-8HH MEDPASS

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·March 5, 2025

    BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 169-157, BD PYXIS MB TWR MN 1FM-10HH-1FH MP/ 169-143, BD PYXIS MB TWR MN 2FH-1FM-4HH-2FM MP/ 169-145, BD PYXIS MB TWR MN 2FM-8HH-1FH MP/ 169-144, BD PYXIS MB TWR MN 4FH-4HH-1FM MP/ 169-142, BD PYXIS MB TWR RXNOW MAIN W/MED PRINTER / 169-155, BD PYXIS MB TWR RXNOW MAIN W/PAT PRINTER/ 169-156, BD PYXIS MDBANK TWR MN 7HH-1HM-3FM/ 169-132, BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow/ 169-131, BD PYXIS MEDBANK TWR MN 10HH-1FH-1FM/ 169-23, BD PYXIS MEDBANK TWR MN 10HH-2FH/ 169-24, BD PYXIS MEDBANK TWR MN 10HH-2FM/ 169-25, BD PYXIS MEDBANK TWR MN 12HH-1FF/ 169-26, BD PYXIS MEDBANK TWR MN 12HH-1FH/ 169-27, BD PYXIS MEDBANK TWR MN 12HH-1FM/ 169-28, BD PYXIS MEDBANK TWR MN 14HH/ 169-29, BD PYXIS MEDBANK TWR MN 1FH-10HM-1FM/ 169-138, BD PYXIS MEDBANK TWR MN 1HH-1HM-2FM-4FF/ 169-30, BD PYXIS MEDBANK TWR MN 2FH-2HM-4FM/ 169-31, BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM/ 169-32, BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM/ 169-33, BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM/ 169-34, BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF/ 169-35, BD PYXIS MEDBANK TWR MN 2HH-4FH-2FM/ 169-139, BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF/ 169-36, BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM/ 169-37, BD PYXIS MEDBANK TWR MN 2HH-6FM/ 169-38, BD PYXIS MEDBANK TWR MN 2HH-6HM-3FM/ 169-39, BD PYXIS MEDBANK TWR MN 2HH-8HM-2FM/ 169-40, BD PYXIS MEDBANK TWR MN 2HM-6FM/ 169-41, BD PYXIS MEDBANK TWR MN 3FH-4FM/ 169-42, BD PYXIS MEDBANK TWR MN 3FH-8HH MEDPASS/ 169-140, BD PYXIS MEDBANK TWR MN 3HH-7HM-2FM/ 169-43, BD PYXIS MEDBANK TWR MN 4HH-10HM/ 169-44, BD PYXIS MEDBANK TWR MN 4HH-1FH-2HM-3FM/ 169-45, BD PYXIS MEDBANK TWR MN 4HH-1FH-4FM/ 169-46, BD PYXIS MEDBANK TWR MN 4HH-1FH-4HM-2FM/ 169-47, BD PYXIS MEDBANK TWR MN 4HH-1FH-6HM-1FM/ 169-48, BD PYXIS MEDBANK TWR MN 4HH-2FH-2HM-2FM/ 169-49, BD PYXIS MEDBANK TWR MN 4HH-2FH-3FM/ 169-50, BD PYXIS MEDBANK TWR MN 4HH-2HM-4FM/ 169-51, BD PYXIS MEDBANK TWR MN 4HH-3FH-2FM/ 169-52, BD PYXIS MEDBANK TWR MN 4HH-4FH-1FM/ 169-53, BD PYXIS MEDBANK TWR MN 4HH-4HM-3FM/ 169-54, BD PYXIS MEDBANK TWR MN 4HH-5FH / 169-55, BD PYXIS MEDBANK TWR MN 4HH-5FM/ 169-56, BD PYXIS MEDBANK TWR MN 4HH-6HM-2FM/ 169-57, BD PYXIS MEDBANK TWR MN 4HH-8HM-1FM/ 169-58, BD PYXIS MEDBANK TWR MN 4HM-5FM/ 169-59, BD PYXIS MEDBANK TWR MN 5HH-3HM-3FM/ 169-60, BD PYXIS MEDBANK TWR MN 5HH-9HM/ 169-61, BD PYXIS MEDBANK TWR MN 6FH-1FM/ 169-62, BD PYXIS MEDBANK TWR MN 6HH-1FH-2HM-2FM/ 169-63, BD PYXIS MEDBANK TWR MN 6HH-1FH-3FM/ 169-64, BD PYXIS MEDBANK TWR MN 6HH-2FH-2FM/ 169-65, BD PYXIS MEDBANK TWR MN 6HH-2FH-2HM-1FM/ 169-66, BD PYXIS MEDBANK TWR MN 6HH-4FH / 169-67, BD PYXIS MEDBANK TWR MN 6HH-4FM/ 169-68, BD PYXIS MEDBANK TWR MN 6HH-4HM-2FM/ 169-69, BD PYXIS MEDBANK TWR MN 6HH-6HM-1FM/ 169-70, BD PYXIS MEDBANK TWR MN 6HH-8HM/ 169-71, BD PYXIS MEDBANK TWR MN 7FH/ 169-72, BD PYXIS MEDBANK TWR MN 7FM/ 169-73, BD PYXIS MEDBANK TWR MN 7HH-1HM-3FM/ 169-74, BD PYXIS MEDBANK TWR MN 8HH-1FH-2FM/ 169-75, BD PYXIS MEDBANK TWR MN 8HH-1FH-2HM-1FM/ 169-76, BD PYXIS MEDBANK TWR MN 8HH-2FH-1FM/ 169-77, BD PYXIS MEDBANK TWR MN 8HH-2HM-2FM/ 169-78, BD PYXIS MEDBANK TWR MN 8HH-3FF/ 169-79, BD PYXIS MEDBANK TWR MN 8HH-3FH/ 169-80, BD PYXIS MEDBANK TWR MN 8HH-3FM/ 169-81, BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P/ 169-82, BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P/ 169-83, BD PYXIS MEDBANK TWR MN CR-12HH-1FH/ 169-84, BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P/ 169-85, BD PYXIS MEDBANK TWR MN CR-14HH-P/ 169-86, BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM/ 169-87, BD PYXIS MEDBANK TWR MN CR-2HH-6FH/ 169-88, BD PYXIS MEDBANK TWR MN CR-2HH-6FM/ 169-89, BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P/ 169-90, BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P/ 169-91, BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P/ 169-92, BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P/ 169-93, BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P/ 169-94, BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P/ 169-95, BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P/ 169-96, BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P/ 169-97, BD

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·July 10, 2024

    Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.

    FDA Enforcement
    Class II ·Terminated·FMS, Finapres Medical Systems BV·August 15, 2012

    139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEX MN 1000 2HH-5FM 139038-01 BD PYXIS MEDFLEX MN 1000 3FM 139040-01 BD PYXIS MEDFLEX MN 1000 4HH-1FM 139049-01 BD PYXIS MEDFLEX MN 1000 4HH-4FM 139044-01 BD PYXIS MEDFLEX MN 1000 6FM 139039-01 BD PYXIS MEDFLEX MN 1000 6HH 139051-01 BD PYXIS MEDFLEX MN 1000 6HH-3FM 139164-01 BD PYXIS MEDFLEX MN 1000 8HH-2FH 139052-01 BD PYXIS MEDFLEX MN 1000 8HH-2FM 139070-01 BD PYXIS MEDFLEX MN 2000 10HH-1FM 139071-01 BD PYXIS MEDFLEX MN 2000 12HH 139061-01 BD PYXIS MEDFLEX MN 2000 2HH-2FM 139066-01 BD PYXIS MEDFLEX MN 2000 2HH-3FM-1DD 139065-01 BD PYXIS MEDFLEX MN 2000 2HH-5FM 139058-01 BD PYXIS MEDFLEX MN 2000 3FM 139060-01 BD PYXIS MEDFLEX MN 2000 4HH-1FM 139067-01 BD PYXIS MEDFLEX MN 2000 4HH-4FM 139064-01 BD PYXIS MEDFLEX MN 2000 6FM 139059-01 BD PYXIS MEDFLEX MN 2000 6HH 139068-01 BD PYXIS MEDFLEX MN 2000 6HH-3FM 139165-01 BD PYXIS MEDFLEX MN 2000 8HH-2FH 139069-01 BD PYXIS MEDFLEX MN 2000 8HH-2FM 1139-00 MEDFLEX 2.0 1119-00 MEDFLEX

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·March 5, 2025

    155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 138921-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 155159-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 169-101 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 139122-01 BD PYXIS MEDBANK MINI 1HH-1HM-1FM 155160-01 BD PYXIS MEDBANK MINI 1HH-1HM-1FM 169-102 BD PYXIS MEDBANK MINI 1HH-1HM-1FM 138912-01 BD PYXIS MEDBANK MINI 1HH-3HM 155161-01 BD PYXIS MEDBANK MINI 1HH-3HM 169-103 BD PYXIS MEDBANK MINI 1HH-3HM 138902-01 BD PYXIS MEDBANK MINI 2FH 169-104 BD PYXIS MEDBANK MINI 2FH 138903-01 BD PYXIS MEDBANK MINI 2FM 155163-01 BD PYXIS MEDBANK MINI 2FM 169-105 BD PYXIS MEDBANK MINI 2FM 138908-01 BD PYXIS MEDBANK MINI 2HH-1FH 169-106 BD PYXIS MEDBANK MINI 2HH-1FH 138906-01 BD PYXIS MEDBANK MINI 2HH-1FM 155165-01 BD PYXIS MEDBANK MINI 2HH-1FM 169-107 BD PYXIS MEDBANK MINI 2HH-1FM 138907-01 BD PYXIS MEDBANK MINI 2HH-2HM 155166-01 BD PYXIS MEDBANK MINI 2HH-2HM 169-108 BD PYXIS MEDBANK MINI 2HH-2HM 139131-01 BD PYXIS MEDBANK MINI 2HM-1FM 155167-01 BD PYXIS MEDBANK MINI 2HM-1FM 169-109 BD PYXIS MEDBANK MINI 2HM-1FM 139091-01 BD PYXIS MEDBANK MINI 3HH-1FG 155168-01 BD PYXIS MEDBANK MINI 3HH-1FG 169-110 BD PYXIS MEDBANK MINI 3HH-1FG 138909-01 BD PYXIS MEDBANK MINI 3HH-1HM 155169-01 BD PYXIS MEDBANK MINI 3HH-1HM 169-111 BD PYXIS MEDBANK MINI 3HH-1HM 138910-01 BD PYXIS MEDBANK MINI 4HH 155310-01 BD PYXIS MEDBANK MINI 4HH 169-112 BD PYXIS MEDBANK MINI 4HH 138915-01 BD PYXIS MEDBANK MINI 4HM 155171-01 BD PYXIS MEDBANK MINI 4HM 169-113 BD PYXIS MEDBANK MINI 4HM 1147-00 MEDBANK MINI MAIN 138943-01 BD PYXIS MEDBANK TWR MN 10HH-1FH-1FM 155081-01 BD PYXIS MEDBANK TWR MN 10HH-1FH-1FM 169-23 BD PYXIS MEDBANK TWR MN 10HH-1FH-1FM 138955-01 BD PYXIS MEDBANK TWR MN 10HH-2FH 155082-01 BD PYXIS MEDBANK TWR MN 10HH-2FH 169-24 BD PYXIS MEDBANK TWR MN 10HH-2FH 138924-01 BD PYXIS MEDBANK TWR MN 10HH-2FM 155083-01 BD PYXIS MEDBANK TWR MN 10HH-2FM 169-25 BD PYXIS MEDBANK TWR MN 10HH-2FM 138960-01 BD PYXIS MEDBANK TWR MN 12HH-1FF 155084-01 BD PYXIS MEDBANK TWR MN 12HH-1FF 169-26 BD PYXIS MEDBANK TWR MN 12HH-1FF 138961-01 BD PYXIS MEDBANK TWR MN 12HH-1FH 155085-01 BD PYXIS MEDBANK TWR MN 12HH-1FH 169-27 BD PYXIS MEDBANK TWR MN 12HH-1FH 138926-01 BD PYXIS MEDBANK TWR MN 12HH-1FM 155086-01 BD PYXIS MEDBANK TWR MN 12HH-1FM 169-28 BD PYXIS MEDBANK TWR MN 12HH-1FM 138927-01 BD PYXIS MEDBANK TWR MN 14HH 155087-01 BD PYXIS MEDBANK TWR MN 14HH 169-29 BD PYXIS MEDBANK TWR MN 14HH 155293-01 BD PYXIS MEDBANK TWR MN 1FH-10HM-1FM 169-138 BD PYXIS MEDBANK TWR MN 1FH-10HM-1FM 155303-01 BD PYXIS MEDBANK TWR MN 1FM-10HH-1FH 139082-01 BD PYXIS MEDBANK TWR MN 1HH-1HM-2FM-4FF 155088-01 BD PYXIS MEDBANK TWR MN 1HH-1HM-2FM-4FF 169-30 BD PYXIS MEDBANK TWR MN 1HH-1HM-2FM-4FF 155305-01 BD PYXIS MEDBANK TWR MN 2FH-1FM-4HH-2FM 139056-01 BD PYXIS MEDBANK TWR MN 2FH-2HM-4FM 155089-01 BD PYXIS MEDBANK TWR MN 2FH-2HM-4FM 169-31 BD PYXIS MEDBANK TWR MN 2FH-2HM-4FM 155304-01 BD PYXIS MEDBANK TWR MN 2FM-8HH-1FH 139045-01 BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM 155090-01 BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM 169-32 BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM 138932-01 BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM 155091-01 BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM 169-33 BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM 139084-01 BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM 155092-01 BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM 169-34 BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM 138963-01 BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF 155093-01 BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF 169-35 BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF 155294-01 BD PYXIS MEDBANK TWR MN 2HH-4FH-2FM 169-139 BD PYXIS MEDBANK TWR MN 2HH-4FH-2FM 138938-01 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF 155094-01 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF 169-36 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF 139125-01 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM 155095-01 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM 169-37 BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM 138919-01 BD PYXIS MEDBANK TWR MN 2HH-6FM 155096-01 BD PYXIS MEDBANK TWR MN 2HH-6FM 169-38 BD PYXIS MEDBANK TWR MN 2HH-6

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·March 5, 2025

    NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

    FDA Enforcement
    Class II ·Terminated·NEUSOFT MEDICAL SYSTEMS IMP & EX·February 13, 2019