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    Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants.

    FDA Recall
    Terminated ·Ge Healthcare It·Product code LLZ·June 15, 2012

    LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 114758 114759 114716 114717 114748 114749 114708 114709 114718 114719 CP561429 CP561430 CP561431 CP561432 CP561442 CP561449 CP561488 CP561489 CP561709 CP561710 CP561714 CP561715 PM555203 Product Usage: Total Elbow Replacement

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code PIX·August 21, 2019

    Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CIX The Albumin BCG assay is used for the quantitation of albumin in human serum or plasma

    FDA Recall
    Terminated ·Abbott Laboratories Inc.·Product code CIX·March 10, 2010

    CA500 Epix Universal Clip Applier Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code MCH·December 22, 2015

    Epix Universal Clip Applier, REF: CA500, STERILEEO

    FDA Recall
    Open, Classified ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code MDM·January 30, 2024

    Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code NWV·March 17, 2020

    EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx Only, UDI: 00812499030013

    FDA Recall
    Open, Classified ·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021

    Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.

    FDA Recall
    Terminated ·Water Pik, Inc.·Product code JET·July 2, 2018

    EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,SterileEO, Rx Only, UDI: 00812499030006

    FDA Recall
    Open, Classified ·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021

    EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303

    FDA Recall
    Open, Classified ·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021

    Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand held button initiated injector device, and a soft seal nozzle affixed to the white injector. The product is sold individually in white, blue red and orange cartons with a photo of the device as well as a stream of water flowing through it. The contents of the container include the device as well as a package insert with utilization instructions. Product Usage: Sinus washing device to keep sinus passages clear of congestion.

    FDA Recall
    Terminated ·Water Pik, Inc.·Product code KMA·April 3, 2012

    EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198

    FDA Recall
    Open, Classified ·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021

    EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF: CEDT200L, Sterile EO, UDI: 00812499030259

    FDA Recall
    Open, Classified ·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021

    EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB300S, SterileEO, UDI: 00812499030358

    FDA Recall
    Open, Classified ·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021

    Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code NWV·March 17, 2020

    Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm REF CW002 QTY: 1 - Product Usage: The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic surgical procedures where the device is introduced into the body through a cannula. The device may be used for the evacuation of smoke created by electrosurgery at the surgical site.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code GEI·December 12, 2018

    Applied Medicals Epix and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code NWV·May 1, 2013

    STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code MCH·December 22, 2015

    STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code MCH·December 22, 2015

    STD KIT GK260, Standard Set 360 Z Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code MCH·December 22, 2015