BEUDAMED
    36 results · 6ms · Sources: EU EUDAMED, US FDA

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

    LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ LPS-FLEX GSF OPT SZ D-R¿ LPS-FLEX GSF OPT SZ E-L¿ LPS-FLEX GSF OPT SZ E-R¿ LPS-FLEX GSK OPT SZ F-L¿ LPS-FLEX GSF OPT SZ F-R¿ LPS-FLEX GSF OPT SZ G-L¿ LPS-FLEX GSF OPT SZ G-R¿

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    CR-FLEX OPT FEM C-L CR-FLEX OPT FEM C-R CR-FLEX OPT FEM D-L CR-FLEX OPT FEM D-R CR-FLEX OPT FEM E-L CR-FLEX OPT FEM E-R CR-FLEX OPT FEM F-L CR-FLEX OPT FEM F-R CR-FLEX OPT FEM G-L CR-FLEX OPT FEM G-R This device is indicated for patients with severe knee pain and disability

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    CR-FLEX OPT FEM C-R MINUS CR-FLEX OPT FEM D-L MINUS CR-FLEX OPT FEM D-R MINUS CR-FLEX OPT FEM E-L MINUS CR-FLEX OPT FEM E-R MINUS CR-FLEX OPT FEM F-L MINUS CR-FLEX OPT FEM F-R MINUS CR-FLEX OPT FEM G-L MINUS CR-FLEX OPT FEM G-R MINUS This device is indicated for patients with severe knee pain and disability

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator,Engl Opt: CFLEX,AVAPS V60 Us Demo Unit V60 USED ENGL OPT:CFLEX, AVAPS,PPV,AT+cl V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ Catalog/REF No. 1053613, 1053614, 1053615, 1053616, 1053617, DU1053617, U1053617, 1076709, R1076709

    FDA Enforcement
    Class II ·Terminated·Respironics California Inc·April 5, 2017

    NexGen¿ Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ C-R MINUS ;CR-FLEX GSF PRECOAT SZ D-L; CR-FLEX GSF PRECOAT SZ D-R ;CR-FLEX GSF PCT SZ D-L MINUS ; CR-FLEX GSF PCT SZ D-R MINUS ;CR-FLEX GSF PRECOAT SZ E-L CR-FLEX GSF PRECOAT SZ E-R ;CR-FLEX GSF PCT SZ E-L MINUS ;CR-FLEX GSF PCT SZ E-R MINUS ;CR-FLEX GSF PRECOAT SZ F-L ;CR-FLEX GSF PRECOAT SZ F-R ;CR-FLEX GSF PCT SZ F-L MINUS ;CR-FLEX GSF PCT SZ F-R MINUS ;CR-FLEX GSF PRECOAT SZ G-L ;CR-FLEX GSK PRECOAT SZ G-R ;CR-FLEX GSF PCT SZ G-L MINUS ;CR-FLEX GSF PCT SZ G-R MINUS ; LPS-FLEX GSF OPT SZ C-L ; LPS-FLEX GSF OPT SZ C-R ;LPS-FLEX GSF OPT SZ D-L ;LPS-FLEX GSF OPT SZ D-R ;LPS-FLEX GSF OPT SZ E-L ;LPS-FLEX GSF OPT SZ E-R ;LPS-FLEX GSK OPT SZ F-L ;LPS-FLEX GSF OPT SZ F-R ;LPS-FLEX GSF OPT SZ G-L ; LPS-FLEX GSF OPT SZ G-R ;CR-FLEX PCT FEM B-L; CR-FLEX PCT FEM B-R; CR-FLEX PCT FEM C-L; CR-FLEX PCT FEM C-R; CR-FLEX PCT FEM C-L MINUS; CR-FLEX PCT FEM C-R MINUS; CR-FLEX PCT FEM D-L; CR-FLEX PCT FEM D-R; CR-FLEX PCT FEM D-L MINUS; CR-FLEX PCT FEM D-R MINUS; CR-FLEX PCT FEM E-L; CR-FLEX PCT FEM E-R; CR-FLEX PCT FEM E-L MINUS; CR-FLEX PCT FEM E-R MINUS; CR-FLEX PCT FEM F-L; CR-FLEX PCT FEM F-R; CR-FLEX PCT FEM F-L MINUS; CR-FLEX PCT FEM F-R MINUS; CR-FLEX PCT FEM G-L; CR-FLEX PCT FEM G-R; CR-FLEX PCT FEM G-L MINUS; CR-FLEX PCT FEM G-R MINUS; CR-FLEX POR FEM B-L; CR-FLEX POR FEM B-R; CR-FLEX POR FEM C-L; CR-FLEX POR FEM C-R; CR-FLEX POR FEM C-L MINUS; CR-FLEX POR FEM C-R MINUS; CR-FLEX POR FEM D-L; CR-FLEX POR FEM D-R; CR-FLEX POR FEM D-L MINUS; CR-FLEX POR FEM D-R MINUS; CR-FLEX POR FEM E-L; CR-FLEX POR FEM E-R; CR-FLEX POR FEM E-L MINUS; CR-FLEX POR FEM E-R; MINUS; CR-FLEX POR FEM F-L; CR-FLEX POR FEM F-R ;CR-FLEX POR FEM F-L MINUS; CR-FLEX POR FEM F-R MINUS; CR-FLEX POR FEM G-L; CR-FLEX POR FEM G-R; CR-FLEX POR FEM G-L MINUS CR-FLEX POR FEM G-R MINUS; CR-FLEX OPT FEM B-L; CR-FLEX OPT FEM B-R; CR-FLEX OPT FEM C-L; CR-FLEX OPT FEM C-R; CR-FLEX OPT FEM C-L MINUS; CR-FLEX OPT FEM C-R MINUS; CR-FLEX OPT FEM D-L; CR-FLEX OPT FEM D-R; CR-FLEX OPT FEM D-L MINUS; CR-FLEX OPT FEM D-R MINUS; CR-FLEX OPT FEM E-L; CR-FLEX OPT FEM E-R; CR-FLEX OPT FEM E-L MINUS; CR-FLEX OPT FEM E-R MINUS; CR-FLEX OPT FEM F-L; CR-FLEX OPT FEM F-R; CR-FLEX OPT FEM F-L MINUS; CR-FLEX OPT FEM F-R MINUS; CR-FLEX OPT FEM G-L; CR-FLEX OPT FEM G-R; CR-FLEX OPT FEM G-L MINUS; CR-FLEX OPT FEM G-R MINUS; LPS-FLEX CO-NID FEM A-L ; LPS-FLEX CO-NID FEM A-R ; LPS-FLEX RECOAT FEMORAL A-L; LPS-FLEX PRECOAT FEMORAL A-R; LPS-FLEX CO-NID FEM B-L ; LPS-FLEX CO-NID FEM B-R ; LPS-FLEX PRECOAT FEMORAL B-L; LPS-FLEX PRECOAT FEMORL B-R; LPS-FLEX CO-NID FEM C-L ; LPS-FLEX CO-NID FEM C-R ; LPS-FLEX PRECOAT FEMORAL C-L; LPS-FLEX PRECOAT FEMORAL C-R; LPS-FLEX CO-NID FEM D-L ; LPS-FLEX CO-NID FEM D-R ; LPS-FLEX PRECOAT FEMORAL D-L; LPS-FLEX PRECOAT FEMORAL D-R; LPS-FLEX CO-NID FEM E-L ; LPS-FLEX CO-NID FEM E-R ; LPS-FLEX PRECOAT FEMORAL E-L; LPS-FLEX PRECOAT FEMORAL E-R; LPS-FLEX CO-NID FEM F-L ; LPS-FLEX CO-NID FEM F-R ; LPS-FLEX PRECOAT FEMORAL F-L; LPS-FLEX PRECOAT FEMORAL F-R; LPS-FLEX CO-NID FEM G-L ; LPS-FLEX CO-NID FEM G-R ; LPS-FLEX PRECOAT FEMORAL G-L; LPS-FLEX PRECOAT FEMORAL G-R; LPS-FLEX PRECOAT FEMORAL H-L; LPS-FLEX PRECOAT FEMORAL H-R ; LPS-FLEX POROUS FEMORAL B-L ; LPS-FLEX POROUS FEMORAL B-R ; LPS-FLEX POROUS FEMORAL C-L ; LPS-FLEX POROUS FEMORAL C-R LPS-FLEX POROUS FEMORAL D-L ; LPS-FLEX POROUS FEMORAL D-R ; LPS-FLEX POROUS FEMORAL E-L ; LPS-FLEX POROUS FEMORAL E-R ; LPS-FLEX POROUS FEMORAL F-L ; LPS-FLEX POROUS FEMORAL F-R ;LPS-FLEX POROUS FEMORAL G-L ; LPS-FLEX POROUS FEMORAL G-R ; LPS-FLEX POROUS FEMORAL H-L ; LPS-FLEX POROUS FEMORAL H-R ; LPS-FLEX OPTION FEMORAL A-L; LPS-FLEX OPTION FEMORAL A-R; LPS-FLEX OPTION FEMORAL B-L; LPS-FLEX OPTION FEMORAL B-R; LPS-FLEX OPTION FEMORAL B-L ; LPS-FLEX OPTION FEMORAL B-R ; LPS-FLEX OPTION FEMORAL C-L; LPS-FLEX OPTION FEMORAL C-R; LPS-FLEX OPTION FEMORAL C-L; LPS-FLEX OPTION FEMORAL C-R; LPS-FLEX OPTI

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·November 6, 2013

    00595601201 Femur CR-FLEX OPT FEM B-L Rx Sterile; 00595601202 Femur CR-FLEX OPT FEM B-R Rx Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

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

    OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt.

    FDA Enforcement
    Class II ·Terminated·Acumed LLC·January 18, 2017

    Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.

    FDA Enforcement
    Class II ·Terminated·The Binding Site Group, Ltd.·January 25, 2017

    Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set ST0560; NM1092R + NM1095R + NM1096R (Tray insert to NM1095R) univation XF ST0540; NM1093R univation XF OPT ST0544

    FDA Enforcement
    Class II ·Terminated·Aesculap Implant Systems LLC·September 29, 2021

    Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures

    FDA Enforcement
    Class II ·Terminated·Haemonetics Corporation·September 5, 2018

    Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

    FDA Enforcement
    Class II ·Terminated·Respironics California, LLC·February 3, 2021

    VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1) Moderate to severe heart failure (NYHA Class III-IV) with EF d 35% and QRS duration e 120 ms; (2) Left bundle branch block (LBBB) with QRS duration e 130 ms, EF d 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·November 15, 2017

    Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

    FDA Enforcement
    Class II ·Terminated·Respironics California, LLC·February 3, 2021

    Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

    FDA Enforcement
    Class II ·Terminated·Respironics California, LLC·February 3, 2021

    Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher. The I.V. poles are stationary, height adjustable stands intended to hold infusion liquids, infusion accessories, and/or other medical devices. They may be used on the following parent devices: Model 2030 (EPIC II), model 3005 S3 beds and stretcher. models 1105, 1105E, 1105X, 1105XE, 1115, 1115E, 1115X, 1115XE, 1125E, 1125X and 1125XE.

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·December 9, 2015

    Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·November 11, 2015

    GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold only outside the U.S. under the following product names: CT OPTIMA 660, CT OPTIMA 660 LONG BJG SKD RUS, CT OPTIMA 660 LONG BJG SKD RUSSIA, CT OPTIMA 660 MID BJG SKD RUSSIA, CT OPTIMA 660 SE, CT OPTIMA 660 SE ASIR, CT660 M40 LONG, CT660 M40 MID, CT660 M40 MID WAUK SKD, CT660 M40 MID WAUK SKD BRAZ, CT660 M40 MID WAUK SKD BRAZ, OPT 660 M40 MID HINO SKD RUS, OPTIMA 660, OPTIMA 660 1.5, OPTIMA 660 1.5 BRAZIL, OPTIMA 660 1.5 BRAZIL SKD W, OPTIMA 660 1.5 BRAZIL SKD WAUK, OPTIMA 660 LONG BJG, OPTIMA 660 M40, OPTIMA 660 M40 3.5 LONG BJG, OPTIMA 660 M40 LONG BJG, OPTIMA 660 M40 LONG BJG SKD RUSS, OPTIMA 660 M40 MID BJG, OPTIMA 660 M40 MID BJG SKD RUSS, OPTIMA 660 MID BJG, OPTIMA 660 MID BJG SKD, OPTIMA CT 660, OPTIMA CT660, OPTIMA CT660 ASIR 128 M RU, OPTIMA CT660 FREEDOM LG HN2.5, OPTIMA CT660 FREEDOM MD BJG2.5, OPTIMA CT660 MID P1.5 HINO, OPTIMA CT660 SE ASIR, OPTIMA CT660 SE GT 1700 HN2.5, OPTIMA CT660 SE GT 2000 BJG2.5, OPTIMA CT660 SKD BRAZIL, OPTIMA CT660S L RU

    FDA Enforcement
    Class II ·Terminated·GE Healthcare Japan Corporation·August 29, 2018

    Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

    FDA Enforcement
    Class II ·Terminated·Respironics California, LLC·February 3, 2021

    GE Healthcare Optima CT660. Sold under the following product names: BEIJING OPTIMA CT660 PRO GT170, BEIJING OPTIMA CT660 PRO GT200, BEIJING OPTIMA CT660S PRO 32 S, CT GOLDSEAL, CT GOLDSEAL OPTIMA 660, CT GOLDSEAL OPTIMA 660 UT-BUC, CT OPTIMA 660 LNG HN P20, CT OPTIMA 660 MID HN P20, CT OPTIMA 660 PRO, CT OPTIMA 660 PRO LONG BJG P2., CT OPTIMA 660 PRO MID, CT OPTIMA 660 PRO MID HN P20, CT OPTIMA 660S LNG HN P20, CT OPTIMA CT660 GT 1700, CT OPTIMA CT660 GT1700, CT OPTIMA CT660 GT1700V, CT OPTIMA CT660 PRO GT1700, CT OPTIMA CT660 PRO LNG P1.5 H, CT OPTIMA CT660 PRO MID P1.5 H, CT OPTIMA CT660 SE GT 1700, CT OPTIMA CT660 SE GT2000, CT660, CT660 ASIR OPT, OPT CT660 FREEDOM GT1700 MKE25, OPT CT660 FREEDOM GT1700 MKE25, OPT CT660 FREEDOM GT2000 MKE25, OPTI660_A_G_1.5, OPTI660_A_L_2.0, OPTI660_N_G_1.5, OPTI660_N_G_2.0, OPTI660_N_L_2.0, OPTIMA 660 DIVA, OPTIMA 660 LNG HN P20, OPTIMA 660 LNG HN P20, OPTIMA 660 LONG, OPTIMA 660 LONG BJG P2.0, OPTIMA 660 LONG WSO, OPTIMA 660 MID, OPTIMA 660 MID BJG P1.5, OPTIMA 660 MID HN P20, OPTIMA 660 MID HN P20, OPTIMA 660 MID WSO, OPTIMA 660 PRO LGN HN P20, OPTIMA 660 PRO LONG BJG P1.5_, OPTIMA 660 PRO LONG BJG P2, OPTIMA 660 PRO LONG BJG P2.0, OPTIMA 660 PRO LONG BJG P2.0, OPTIMA 660 PRO LONG WSO, OPTIMA 660 PRO MID BJG P1.5, OPTIMA 660 PRO MID BJG P2.0, OPTIMA 660 PRO MID H, OPTIMA 660 PRO MID HN P20, OPTIMA 660 PRO MID WSO, OPTIMA 660 WSO, OPTIMA 660S 32 OPTIMA 660S 32 SLICE LONG WSO, OPTIMA 660S 32 SLICE MID WSO, OPTIMA 660S LNG HN P20, OPTIMA 660S MID BJG P2.0, OPTIMA 660S PRO 32 SLICE M WSO, OPTIMA 660S PRO LONG BJG P2.0, OPTIMA 660S PRO MID BJG P1.5, OPTIMA 660S WSO, OPTIMA CT 660 FREEDOM, OPTIMA CT660, OPTIMA CT660 2ND EDITION, OPTIMA CT660 ASIR, OPTIMA CT660 ASIR ADV 2ND, OPTIMA CT660 FREEDOM, OPTIMA CT660 FREEDOM LG BJG2.5, OPTIMA CT660 FREEDOM LG BJG2.5, OPTIMA CT660 FREEDOM LG HN2, OPTIMA CT660 FREEDOM LG HN2.5, OPTIMA CT660 FREEDOM MD, OPTIMA CT660 FREEDOM MD BJG2., OPTIMA CT660 GS, OPTIMA CT660 GT 1700 BJG2, OPTIMA CT660 GT 1700 BJG2.5, OPTIMA CT660 GT 1700 HN P2, OPTIMA CT660 GT 1700 HN P2., OPTIMA CT660 GT 1700 HN P2.5, OPTIMA CT660 GT 2000 HN P2.5, OPTIMA CT660 GT1700, OPTIMA CT660 GT1700 MKE2.5, OPTIMA CT660 GT1700 PHASE 1.5, OPTIMA CT660 GT2000, OPTIMA CT660 GT2000, OPTIMA CT660 GT2000 PHASE 1.5, OPTIMA CT660 LITE, OPTIMA CT660 LITE HN P2.5, OPTIMA CT660 MID P1.5 HINO, OPTIMA CT660 MID P20, OPTIMA CT660 MID P2000, OPTIMA CT660 PRO, OPTIMA CT660 PRO GT 2000, OPTIMA CT660 PRO GT1700, OPTIMA CT660 PRO GT1700 ASIR, OPTIMA CT660 PRO GT1700 P20, OPTIMA CT660 PRO GT1700 PHASE, OPTIMA CT660 PRO GT1700 PHASE 1.5, OPTIMA CT660 PRO GT1700V, OPTIMA CT660 PRO GT1700V ASIR, OPTIMA CT660 PRO GT2000, OPTIMA CT660 PRO GT2000 PHASE, OPTIMA CT660 PRO GT2000 PHASE 1.5, OPTIMA CT660 PRO LNG, OPTIMA CT660 PRO LNG P1.5, OPTIMA CT660 PRO LNG P1.5 HINO, OPTIMA CT660 PRO LNG P1.5 HINO, OPTIMA CT660 PRO LONG BJG P2.0, OPTIMA CT660 PRO LONG P2.0, OPTIMA CT660 PRO MID P1.5, OPTIMA CT660 PRO MID P1.5 H, OPTIMA CT660 PRO MID P1.5 HINO, OPTIMA CT660 SE, OPTIMA CT660 SE GT 1700 BJG, OPTIMA CT660 SE GT 1700 BJG2.5, OPTIMA CT660 SE GT 1700 BJG2.5, OPTIMA CT660 SE GT 1700 HN2, OPTIMA CT660 SE GT 2000, OPTIMA CT660 SE GT 2000 BJG, OPTIMA CT660 SE GT 2000 BJG2., OPTIMA CT660 SE GT 2000 BJG2.5, OPTIMA CT660 SE GT 2000 HN2, OPTIMA CT660 SE GT 2000 HN2.5, OPTIMA CT660 SE GT2000 MKE2.5, OPTIMA CT660 SE WITH ASIR, OPTIMA CT660 W/PRO PKG-BR, OPTIMA CT660 W/PRO PKG-LA, OPTIMA CT660-64 USA, OPTIMA CT660S, OPTIMA CT660S, OPTIMA CT660S 32 SLICE GT1700, OPTIMA CT660S 32 SLICE HINO, OPTIMA CT660S GT, OPTIMA CT660S GT 1700 HN2.5, OPTIMA CT660S GT 2000, OPTIMA CT660S GT 2000 BJG2.5, OPTIMA CT660S GT 2000 HN2.5, OPTIMA CT660S GT1700 BJG P2.5, OPTIMA CT660S GT1700 HN P2.5, OPTIMA CT660S PRO 32 HINO, OPTIMA CT660S PRO 32 SLICE, OPTIMA CT660S PRO 32 SLICE GT2, OPTIMA CT660S PRO P1.5 HINO, OPTIMACT660_A_G, OPTIMACT660_A_L, OPTIMACT660_N_G, OPTIMACT660_N_L, REVOLUTION EVO, REVOLUTION EVO WITH GT2000 TABLE (H

    FDA Enforcement
    Class II ·Terminated·GE Healthcare Japan Corporation·August 29, 2018

    Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

    FDA Enforcement
    Class II ·Terminated·Respironics California, LLC·February 3, 2021