4,695 results
·
17ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
"***REF GRE-1***1.85 mm x 16 mm Fluted Router. Use with B-GREEN Attachments.***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126***" Lot number: B053003318. Product Usage: Cutting and shaping bone including bones of the spine and cranium.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HTT·May 19, 2008
Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation.
FDA Enforcement
Class I
·Terminated·Arrow International Inc·July 4, 2012
CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery.
FDA Enforcement
Class II
·Terminated·Invacare Corporation·August 28, 2013
Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.
FDA Enforcement
Class II
·Terminated·Clarity Medical Systems Inc·March 26, 2014
Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.
FDA Recall
Terminated
·Clarity Medical Systems Inc·Product code HKI·March 7, 2014
RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code CHL·May 27, 2020
MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: MOSAIQ¿ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Users can configure MOSAIQ¿ for Medical Oncology use, Radiation Oncology use, or the two together. It lets users: Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications. Generate and keep medication formulary lists and calculate applicable medication dosages for medical oncology. Import, view, annotate, adjust, enhance, manage and archive images. Compare radiation treatment plans and evaluate dose coverage. Design leaf plans for operation with radiotherapy treatment machines that have multileaf collimators. Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine constraints. MOSAIQ¿ reads actual settings from the treatment machine through the machine communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system warns the user. View reference images to setup treatment. MOSAIQ¿ refers to predefined settings to help treatment machine setup, and communicates patient and machine setup instructions. Record actual delivered radiation values in an electronic chart to track treatment. MOSAIQ¿ is not intended for use in diagnosis. Medical oncology dose calculation functions are designed for use with patients 18 years or older only.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·July 5, 2017
Retcam3 & Retcam Shuttle with version 6.0 software. Clarity Medical Systems, Inc. 5775 W. Las Positas Blvd, Suite 200 Pleasanton, CA 94588 General ophthalmic imaging including retinal, corneal and external imaging. Photodocumentation of pediatric ocular diseases including retinopathy or prematurity (ROP). Screening of Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.
FDA Recall
Terminated
·Clarity Medical Systems Inc·Product code HKI·February 2, 2012
SYNCHRON Systems Calibrator 1, Part Numbers: 468405, Lots prior to M005558 The Beckman Coulter SYNCHRON Calibrator 1 (CAL 1), used in conjunction with SYNCHRON reagents, is intended for the calibration of immunoprotein tests on SYNCHRON LX and UniCel DxC Systems.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JIT·March 11, 2011
life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N: 9146-001, Lithium Sulfur Dioxide, Part # 7L877, Voltage 12V, 7.5 amps; Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.
FDA Recall
Terminated
·Exocomm Tech Grp·Product code MKJ·September 3, 2007
life+cel, Replacement battery for Cardiac Science FirstSave Survivalink; OEM P/N:9141-001, Part #: 2L561, Lithium Sulfur Dioxide, Voltage 12V, 7.5 amps., Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.
FDA Recall
Terminated
·Exocomm Tech Grp·Product code MKJ·September 3, 2007
EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60 Vet, iM70 Vet Monitors, and is intended to be used to measuring expired CO2 as part of multi parameter patient monitors. The Patient Monitors are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates, such as ECG, Respiration (RESP), IBP, NIBP, Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG).
FDA Recall
Terminated
·Edan Diagnostics·Product code MHX·June 23, 2016
GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree.
FDA Recall
Terminated
·W.L. Gore & Associates, Inc.·Product code FGE·April 5, 2021
Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
FDA Recall
Terminated
·W L Gore & Associates, Inc.·Product code MIH·December 17, 2019
GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm
FDA Recall
Terminated
·W L Gore & Assoc, Inc.·Product code MIH·April 28, 2006
Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
FDA Recall
Terminated
·W. L. Gore & Associates Inc.·Product code DYB·November 18, 2019
GORE EXCLUDER AAA Endoprosthesis
FDA Recall
Terminated
·W. L. Gore & Associates Inc.·Product code MIH·January 6, 2020
GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)
FDA Recall
Terminated
·W. L. Gore & Associates Inc.·Product code MIH·January 6, 2020
GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm
FDA Recall
Terminated
·W L Gore & Assoc, Inc.·Product code MIH·April 28, 2006
GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
FDA Recall
Terminated
·W L Gore & Associates, Inc.·Product code MIH·September 25, 2017