BEUDAMED
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    EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation

    FDA Recall
    Terminated ·EEG Info·Product code HCC·November 15, 2012

    EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation

    FDA Enforcement
    Class II ·Terminated·EEG Info·December 26, 2012

    Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.

    FDA Recall
    Terminated ·EMG Technology Co., Ltd.·Product code JCX·August 3, 2014

    Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.

    FDA Enforcement
    Class II ·Terminated·EMG Technology Co., Ltd.·September 24, 2014

    Discovery RT labeled as: a. MID BJG; b. HVY BJG

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·May 24, 2018

    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 Recall
    Terminated ·GE Healthcare Japan Corporation Ge Herusukea.Japan Kabu 4 Chome 7-127 Asahigaoka Hino Japan·Product code JAK·April 27, 2018

    Discovery RT labeled as: a. MID BJG; b. HVY BJG

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·August 8, 2018

    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

    GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold under the following product names: CT GOLDSEAL LIGHTSPEED ULTRA, CT OPTIMA 660, CT OPTIMA 660 M40 3.5 LONG BJG, CT OPTIMA 660 M40 GT1700, CT OPTIMA 660 M40 GT1700 BEIJI, CT OPTIMA 660 M40 GT1700 HINO, CT OPTIMA 660 M40 GT2000 BEIJI, CT OPTIMA 660 M40 GT2000 HINO, CT OPTIMA CT 660, CT OPTIMA CT660, CT OPTIMA CT660 M4, CT OPTIMA CT660 M40, CT REVOLUTION EVO 3.5 LONG HIN, CT REVOLUTION EVO VT2000 HINO, CT660 MAR UPGRADE, MOBILE OPTIMA CT 660, OPTI660_A_G_2.0, OPTI660_M40_G, OPTI660_M40_L, OPTIMA 660, OPTIMA 660 128 FOR TW- DIRECT, OPTIMA 660 GT2000 M40 HINO MULTISLICE, OPTIMA 660 M40, OPTIMA 660 M40, OPTIMA 660 M40 3.5 HVY BJG, OPTIMA 660 M40 3.5 LONG BJG, OPTIMA 660 M40 3.5 LONG BJG, OPTIMA 660 M40 3.5 LONG HINO, OPTIMA 660 M40 3.5 MID, OPTIMA 660 M40 3.5 MID BJG, OPTIMA 660 M40 3.5 MID HINO, OPTIMA 660 M40 3.5/6, OPTIMA 660 M40 3.5/6 HVY BJG, OPTIMA 660 M40 3.5/6 HVY HINO, OPTIMA 660 M40 3.5/6 HVY WAUK, OPTIMA 660 M40 3.5/6 LONG, OPTIMA 660 M40 3.5/6 LONG B, OPTIMA 660 M40 3.5/6 LONG BJG, OPTIMA 660 M40 3.5/6 LONG HINO, OPTIMA 660 M40 3.5/6 LONG WAUK, OPTIMA 660 M40 3.5/6 MID BJ, OPTIMA 660 M40 3.5/6 MID BJG, OPTIMA 660 M40 3.5/6 MID HI, OPTIMA 660 M40 3.5/6 MID HINO, OPTIMA 660 M40 3.5/6 MID WA, OPTIMA 660 M40 3.5/6 MID WAUK, OPTIMA 660 M40 GT1700, OPTIMA 660 M40 GT1700 BEIJING, OPTIMA 660 M40 GT1700 HINO, OPTIMA 660 M40 GT1700 WAUK, OPTIMA 660 M40 GT2000 B, OPTIMA 660 M40 GT2000 BEIJI, OPTIMA 660 M40 GT2000 BEIJING, OPTIMA 660 M40 GT2000 HINO, OPTIMA 660 M40 GT2000 WAUK, OPTIMA 660 M40 MOBILE BEIJING, OPTIMA CT 660, OPTIMA CT660 ASIR, OPTIMA CT660 ASIR 128 M RU, OPTIMA CT660 FREEDOM MD HN2, OPTIMA CT660 M40 GT1700, OPTIMA CT660 M40 GT2000, OPTIMA CT660 M40 GT2000 BEIJIN, OPTIMA CT660 M40 GT2000 HINO, OPTIMA CT660 P2.5, OPTIMA CT660 P25 UPG KIT, OPTIMA CT660 PRO MID, OPTIMA CT660 SE, OPTIMA CT660 SE GT 1700, OPTIMA CT680, OPTIMA CT680 KL64 GT1700 BHW, REVOLUTION EVO, REVOLUTION EVO 3.5 HVY BJG, REVOLUTION EVO 3.5 HVY HINO, REVOLUTION EVO 3.5 HVY WAUK, REVOLUTION EVO 3.5 LONG BJG, REVOLUTION EVO 3.5 LONG HINO, REVOLUTION EVO 3.5 LONG WAUK, REVOLUTION EVO 3.5 MID BJG, REVOLUTION EVO 3.5 MID HINO, REVOLUTION EVO 3.5 MID WAUK, REVOLUTION EVO 3.5MID HINO CT, REVOLUTION EVO 3.6 CHN HINO, REVOLUTION EVO 3.6 HVY BJG, REVOLUTION EVO 3.6 HVY HINO, REVOLUTION EVO 3.6 HVY WAUK, REVOLUTION EVO 3.6 LONG, REVOLUTION EVO 3.6 LONG BJG, REVOLUTION EVO 3.6 LONG HIN, REVOLUTION EVO 3.6 LONG HINO, REVOLUTION EVO 3.6 LONG WAUK, REVOLUTION EVO 3.6 MID BJG, REVOLUTION EVO 3.6 MID HINO, REVOLUTION EVO 3.6 MID WAUK, REVOLUTION EVO 3.6B, REVOLUTION EVO 3.6B HVY HINO, REVOLUTION EVO 3.6B LONG, REVOLUTION EVO 3.6B LONG BJG, REVOLUTION EVO 3.6B LONG HINO, REVOLUTION EVO 3.6B MID BJG, REVOLUTION EVO 3.6B MID HINO, REVOLUTION EVO GT1700, REVOLUTION EVO GT2000, REVOLUTION EVO GT2000 HINO, REVOLUTION EVO GT2000X (HINO), REVOLUTION EVO GT2000X HINO, REVOLUTION EVO VT1700 BEIJING, REVOLUTION EVO VT1700 HINO, REVOLUTION EVO VT1700 WAUK, REVOLUTION EVO VT2000 BEIJING, REVOLUTION EVO VT2000 HINO, REVOLUTION EVO VT2000 WAUK, REVOLUTION EVO VT2000X BEIJING, REVOLUTION EVO VT2000X HINO, REVOLUTION EVO VT2000X WAUK, REVOLUTION EVO WITH GT1700V TA, REVOLUTION EVO WITH GT2000 TAB

    FDA Recall
    Terminated ·GE Healthcare Japan Corporation Ge Herusukea.Japan Kabu 4 Chome 7-127 Asahigaoka Hino Japan·Product code JAK·April 27, 2018

    GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold under the following product names: CT GOLDSEAL LIGHTSPEED ULTRA, CT OPTIMA 660, CT OPTIMA 660 M40 3.5 LONG BJG, CT OPTIMA 660 M40 GT1700, CT OPTIMA 660 M40 GT1700 BEIJI, CT OPTIMA 660 M40 GT1700 HINO, CT OPTIMA 660 M40 GT2000 BEIJI, CT OPTIMA 660 M40 GT2000 HINO, CT OPTIMA CT 660, CT OPTIMA CT660, CT OPTIMA CT660 M4, CT OPTIMA CT660 M40, CT REVOLUTION EVO 3.5 LONG HIN, CT REVOLUTION EVO VT2000 HINO, CT660 MAR UPGRADE, MOBILE OPTIMA CT 660, OPTI660_A_G_2.0, OPTI660_M40_G, OPTI660_M40_L, OPTIMA 660, OPTIMA 660 128 FOR TW- DIRECT, OPTIMA 660 GT2000 M40 HINO MULTISLICE, OPTIMA 660 M40, OPTIMA 660 M40, OPTIMA 660 M40 3.5 HVY BJG, OPTIMA 660 M40 3.5 LONG BJG, OPTIMA 660 M40 3.5 LONG BJG, OPTIMA 660 M40 3.5 LONG HINO, OPTIMA 660 M40 3.5 MID, OPTIMA 660 M40 3.5 MID BJG, OPTIMA 660 M40 3.5 MID HINO, OPTIMA 660 M40 3.5/6, OPTIMA 660 M40 3.5/6 HVY BJG, OPTIMA 660 M40 3.5/6 HVY HINO, OPTIMA 660 M40 3.5/6 HVY WAUK, OPTIMA 660 M40 3.5/6 LONG, OPTIMA 660 M40 3.5/6 LONG B, OPTIMA 660 M40 3.5/6 LONG BJG, OPTIMA 660 M40 3.5/6 LONG HINO, OPTIMA 660 M40 3.5/6 LONG WAUK, OPTIMA 660 M40 3.5/6 MID BJ, OPTIMA 660 M40 3.5/6 MID BJG, OPTIMA 660 M40 3.5/6 MID HI, OPTIMA 660 M40 3.5/6 MID HINO, OPTIMA 660 M40 3.5/6 MID WA, OPTIMA 660 M40 3.5/6 MID WAUK, OPTIMA 660 M40 GT1700, OPTIMA 660 M40 GT1700 BEIJING, OPTIMA 660 M40 GT1700 HINO, OPTIMA 660 M40 GT1700 WAUK, OPTIMA 660 M40 GT2000 B, OPTIMA 660 M40 GT2000 BEIJI, OPTIMA 660 M40 GT2000 BEIJING, OPTIMA 660 M40 GT2000 HINO, OPTIMA 660 M40 GT2000 WAUK, OPTIMA 660 M40 MOBILE BEIJING, OPTIMA CT 660, OPTIMA CT660 ASIR, OPTIMA CT660 ASIR 128 M RU, OPTIMA CT660 FREEDOM MD HN2, OPTIMA CT660 M40 GT1700, OPTIMA CT660 M40 GT2000, OPTIMA CT660 M40 GT2000 BEIJIN, OPTIMA CT660 M40 GT2000 HINO, OPTIMA CT660 P2.5, OPTIMA CT660 P25 UPG KIT, OPTIMA CT660 PRO MID, OPTIMA CT660 SE, OPTIMA CT660 SE GT 1700, OPTIMA CT680, OPTIMA CT680 KL64 GT1700 BHW, REVOLUTION EVO, REVOLUTION EVO 3.5 HVY BJG, REVOLUTION EVO 3.5 HVY HINO, REVOLUTION EVO 3.5 HVY WAUK, REVOLUTION EVO 3.5 LONG BJG, REVOLUTION EVO 3.5 LONG HINO, REVOLUTION EVO 3.5 LONG WAUK, REVOLUTION EVO 3.5 MID BJG, REVOLUTION EVO 3.5 MID HINO, REVOLUTION EVO 3.5 MID WAUK, REVOLUTION EVO 3.5MID HINO CT, REVOLUTION EVO 3.6 CHN HINO, REVOLUTION EVO 3.6 HVY BJG, REVOLUTION EVO 3.6 HVY HINO, REVOLUTION EVO 3.6 HVY WAUK, REVOLUTION EVO 3.6 LONG, REVOLUTION EVO 3.6 LONG BJG, REVOLUTION EVO 3.6 LONG HIN, REVOLUTION EVO 3.6 LONG HINO, REVOLUTION EVO 3.6 LONG WAUK, REVOLUTION EVO 3.6 MID BJG, REVOLUTION EVO 3.6 MID HINO, REVOLUTION EVO 3.6 MID WAUK, REVOLUTION EVO 3.6B, REVOLUTION EVO 3.6B HVY HINO, REVOLUTION EVO 3.6B LONG, REVOLUTION EVO 3.6B LONG BJG, REVOLUTION EVO 3.6B LONG HINO, REVOLUTION EVO 3.6B MID BJG, REVOLUTION EVO 3.6B MID HINO, REVOLUTION EVO GT1700, REVOLUTION EVO GT2000, REVOLUTION EVO GT2000 HINO, REVOLUTION EVO GT2000X (HINO), REVOLUTION EVO GT2000X HINO, REVOLUTION EVO VT1700 BEIJING, REVOLUTION EVO VT1700 HINO, REVOLUTION EVO VT1700 WAUK, REVOLUTION EVO VT2000 BEIJING, REVOLUTION EVO VT2000 HINO, REVOLUTION EVO VT2000 WAUK, REVOLUTION EVO VT2000X BEIJING, REVOLUTION EVO VT2000X HINO, REVOLUTION EVO VT2000X WAUK, REVOLUTION EVO WITH GT1700V TA, REVOLUTION EVO WITH GT2000 TAB

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

    Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

    FDA Enforcement
    Class II ·Terminated·Nakanishi Inc.·October 31, 2018

    Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.

    FDA Enforcement
    Class II ·Terminated·Mazor Robotics Ltd·December 26, 2018

    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 Recall
    Terminated ·GE Healthcare Japan Corporation Ge Herusukea.Japan Kabu 4 Chome 7-127 Asahigaoka Hino Japan·Product code JAK·April 27, 2018

    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

    Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

    FDA Enforcement
    Class II ·Terminated·Nakanishi Inc.·October 31, 2018

    SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).

    FDA Recall
    Terminated ·Sarken, Inc.·Product code DJG·July 29, 2013

    Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DJG·September 4, 2019

    Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DJG·February 18, 2014

    Ortho-Jet Powder, fast curing orthodontic acrylic resin; the product was packaged under the following brands and sizes: a.1) Ortho-Jet Powder, Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969, product code 1320, 100 g plastic squeeze bottle; a.2) Biocryl Resin Acrylic, Great Lakes Orthodontics, Ltd., P.O. Box 5111, Towanda, New York 14151-5111, product code 040-016, 1 lb. lab pack with empty plastic squeeze bottle; b.1) Contemporary Colored Ortho-Jet Powder, Lang Dental, product code 1520, 100 g plastic squeeze bottle; b.2) Contemporary Colored Assorted Kit, Great Lakes Orthodontics, product code 045-088, 2 oz. plastic squeeze bottles, 6 bottles per kit; c.1) Electric Colored Ortho-Jet Powder, Lang Dental, product code 2720, 100 g plastic squeeze botles and product code 2793, 45 g plastic squeeze bottles/6 per kit; c.2) Tropical Tones Acrylic Resin, Great Lakes Orthodontics, product code 045-052, 4 oz. plastic squeeze bottle

    FDA Recall
    Terminated ·Lang Dental Mfg Co, Inc.·Product code EBG·June 7, 2004

    TempSpan Dual-Cure Temporary Crown and Bridge Material, PART NUMBER N69AD, The intended use of this device is to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

    FDA Recall
    Terminated ·Jeneric/Pentron·Product code EBG·October 22, 2009