106 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The Monarch Airway Clearance System, Model 1000, is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physicians choice of treatment. It is indicated for patients having difficulty with secretion clearance or the presence of atelectasis caused by mucus plugging.
FDA Enforcement
Class II
·Terminated·HILL-ROM MANUFACTURING, INC.·December 6, 2017
TLC-2000 Therapeutic Medical Laser System
FDA Recall
Terminated
·Theralase Inc.·Product code NHN·September 26, 2019
Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per case. Stick-on label on device and User Instruction sheet are attached to the case with a rubber band.
FDA Recall
Terminated
·EM Innovations Inc·Product code MMK·April 3, 2006
TLC-2000 Therapeutic Medical Laser System
FDA Enforcement
Class III
·Terminated·Theralase Inc.·February 26, 2020
Model 100 enFlow Fluid/Blood Warmer Model Numbers: 980100, 91000103, 91000153, 91000154, 91000156 The device is a medical point-of-care device designed to warm blood and IV fluids.
FDA Recall
Terminated
·Enginivity LLC·Product code LGZ·March 23, 2009
CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
FDA Enforcement
Class I
·Terminated·Thoratec Switzerland GMBH·November 6, 2019
VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·April 13, 2016
Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The Monarch Airway Clearance System, Model 1000, is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physicians choice of treatment. It is indicated for patients having difficulty with secretion clearance or the presence of atelectasis caused by mucus plugging.
FDA Recall
Terminated
·HILL-ROM MANUFACTURING, INC.·Product code BYI·September 15, 2017
Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, McGaw Park, IL 60085 The instrument is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient''s blood, an extracorporeal blood set, and a high permeability dialyzer. The standard features of the Meridian instrument incluide a high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultrafiltration control, standard and variable bicarbonate and sodium capabilities anbd automated chemical disinfection. The Meridian will operate in either the bicarbonate or acetate mode for concentrates.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt·Product code KDI·November 15, 2002
ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; Temperature Controller Board Part #78560-109; distributed by Abbott Laboratories, Irving, TX.
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code JJE·December 12, 2006
ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; Temperature Controller Board Part #78560-109; distributed by Abbott Laboratories, Irving, TX.
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code JJE·December 12, 2006
CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
FDA Recall
Terminated
·Thoratec Switzerland GMBH Technoparkstrasse 1 Zurich Switzerland·Product code KFM·August 22, 2019
AD 7 Patient table supplied with Allura Xper FD10 and Allura Xper FD10/10. Product is non-tilting but can be purchased with a tilt option.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IXI·March 14, 2008
Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health, Minneapolis, MN 55447-1341. Intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
FDA Recall
Terminated
·Product code CBK·January 8, 2010
CDI TM 101 Monitor, CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System, The CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where you need continuous monitoring of the blood's oxygen saturation, hematocrit and hemoglobin levels.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·April 28, 2011
Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product Usage: The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·December 19, 2013
VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JJE·February 16, 2016
REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.
FDA Recall
Terminated
·Meta C.G.M. Spa Via Modena 22-24 Correggio Italy·Product code EMI·April 26, 2021
REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery.
FDA Recall
Terminated
·Meta C.G.M. Spa Via Modena 22-24 Correggio Italy·Product code EMI·April 26, 2021
REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery.
FDA Recall
Terminated
·Meta C.G.M. Spa Via Modena 22-24 Correggio Italy·Product code EMI·April 26, 2021