37 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Pump Tube, REF 8170,121; Suction Pump Drain Tube; An accessory to the suction pump designed for use with the Richard Wolf Ultrasound Lithotriptor used to disintegrate kidney stones, urinary bladder stones and ureter stones; Richard Wolf GmbH, D-75438 Knittlingen Germany
FDA Recall
Terminated
·Richard Wolf Medical Instruments Corp.·Product code JOL·February 2, 2004
SUCTION CATHETER KIT CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code JOL·July 10, 2015
Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
FDA Recall
Terminated
·Teleflex Medical·Product code JOL·January 7, 2019
VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
FDA Recall
Terminated
·Santanello Surgical LLC·Product code JOL·June 10, 2019
Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax.
FDA Recall
Terminated
·Cook Inc.·Product code JOL·September 17, 2019
BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
FDA Recall
Terminated
·Invuity, Inc.·Product code JOL·May 12, 2012
Catalog Number: 900277 SUCTION CATHETER TRAY 14FR WITH SODIUM CHLORIDE 0.9% IRRIGATION Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code JOL·January 7, 2016
Pointe Scientific, Inc. Iron Color Reagent, Pointe Scientific, Inc., Canton, MI., Catalog #s: 7-I7504-COL-15, 7-I7504-COL-5, 7-I7504-COL-60, 8-I7504-COL-15, 8-I7504-COL-60 and 3-I7504-COL. Clinical chemistry reagent for the quantitative determination of iron in serum.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code JIY·November 16, 2009
SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 47235802103 47235802104 47235802106 47235802108 47235802203 47235802204 47235802206 47235802208 47235802210
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 13, 2019
ADVIA Centaur Folate (FOL)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 2, 2018
Action Products, Inc., Bol-X-II, 30x30x1.0cm, item number 32102, packaged 10/carton. Polymer pad used during radiation therapy.
FDA Recall
Terminated
·Action Products Incorporated·Product code JAD·June 26, 2009
Action Products, Inc., Bol-X-II, 30x30x0.5cm, item number 32052, packaged 10/carton. Polymer pad used during radiation therapy.
FDA Recall
Terminated
·Action Products Incorporated·Product code JAD·June 26, 2009
ADVIA Centaur¿ Folate (FOL)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 3, 2013
SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 47235802103 47235802104 47235802106 47235802108 47235802203 47235802204 47235802206 47235802208 47235802210
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code HRS·October 10, 2019
Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in part, "Congruent Plate System... Size: 3.5mm x 14.0 mm Locking Cortical Screw... REF COL-3140-S LOT W46772... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR ". Product is used as an orthopedic implant.
FDA Recall
Terminated
·Acumed LLC·Product code HWC·July 9, 2007
AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code CGN·November 30, 2018
Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 21, 2013
AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·January 2, 2019
Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.
FDA Recall
Terminated
·Computerized Medical Systems Inc·Product code MUJ·November 30, 2007