72 results
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22ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code OUG·January 17, 2020
CADD Administration Sets, Model #21-7346-24
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code FPA·July 14, 2020
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
FDA Recall
Terminated
·Product code NKG·December 14, 2020
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAK·November 24, 2020
NM 830 Model # H3910AC
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
NM/CT 870 DR Model # H3100AS
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
Discovery 670 DR Model # H3100BT
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
NM/CT 860, SPECT/CT
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
Discovery NM 630 Model # H3101RH
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
NM/CT 870 CZT Model # H3906CW
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
NM/CT 850 Model Number: H3907AD
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
Discovery NM670 Pro Model # H3100XB
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
FDA Recall
Open, Classified
·Medtronic CoreValve LLC·Product code DTI·January 14, 2020
Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
FDA Recall
Open, Classified
·Medtronic CoreValve LLC·Product code DTI·January 14, 2020
Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
FDA Recall
Terminated
·Cook Inc.·Product code MIH·January 16, 2020
Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
FDA Recall
Terminated
·Ormco/Sybronendo·Product code EJF·January 14, 2020
This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended to be used based on the devices associated with them. Nylatex wraps are composed of nylon and natural rubber and are accessories used to secure electrodes or thermal therapy to a patient.
FDA Recall
Terminated
·DJO, LLC·Product code IMF·June 25, 2018
SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/healthcare personnel interactions. AAMI Level II isolation gowns are intended for relatively low risk procedures, including blood draws, lab work, or similar.
FDA Recall
Terminated
·Sobel Westex·Product code OEA·August 13, 2020
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
FDA Recall
Terminated
·Quidel Corporation·Product code PSZ·September 25, 2020
Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex Ambu King LTS-D" Supraglottic Airway Kit with ET Tube (hereafter the Kit which contains all of the components necessary to successfully obtain an open patient airway with an Ambu King LTS-D" Supraglottic Airway.
FDA Recall
Terminated
·Bound Tree Medical·Product code CAE·May 14, 2020