35 results
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23ms
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Sources: EU EUDAMED, US FDA
DeRoyal''s SurgiMate (tm) Skin Stapler, Rotating Head, product #25-1001, packaged with 35 or more stainless steel staples in peel away pouch. Pouch is labeled in part, ***sterile, disposable, do not resterilize***. Pouches are packaged 12 per box.
FDA Recall
Terminated
·Product code MNV·February 25, 2003
Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.
FDA Recall
Terminated
·Cordis Neurovascular, Inc.·Product code KRA·August 11, 2006
Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters.
FDA Recall
Terminated
·Cordis Neurovascular, Inc.·Product code KRA·August 11, 2006
Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS
FDA Recall
Terminated
·Lockheed Martin Gyrocam Systems, Inc.·Product code REX·January 21, 2010
CareFusion EnVe Ventilator, Model 19250-001. Manufactured by: CareFusion, 22745 Savi Ranch, Yorba Linda, CA 92887 USA. EnVe is a portable critical care ventilator. It is suitable for a wide range of life support and critical care applications. The ventilator normally operates from external DC power. When the ventilator is portable, a Removable Battery Pack powers the unit. Devices are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs).
FDA Recall
Terminated
·Product code CBK·September 12, 2011
CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.
FDA Recall
Terminated
·Product code CBK·August 8, 2014
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
Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897 Double Basin Set Up Kit 31145249 7897-T8 Double Basin Set Up Kit 31145298 7896-T8 Double Basin Set Up Kit 31145496 7696-T4 Single Basin Set Up Kit 31145520 7614 Single Basin Set Up Kit 31145546 7693 Single Basin Set Up Kit 31145629 7696 Single Basin Set Up Kit 31153938 7756-KST Surgical Set Up Kit 31154266 7656-KST Surgical Set Up Kit 31321097 7697 Surgical Set Up Kit 31324299 7830-HOH Surgical Set Up Kit 31451092 7600-DNV Surgical Set Up Kit 31453098 7682-MHP Surgical Set Up Kit
FDA Recall
Terminated
·Covidien LLC·Product code FSY·April 16, 2015
BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.
FDA Recall
Terminated
·Stryker Sustainability Solutions·Product code NLH·December 17, 2018
CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. It is not intended for homecare use.
FDA Recall
Terminated
·Product code CBK·June 19, 2012
NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
FDA Recall
Terminated
·Blue Belt Technologies MN·Product code OLO·April 11, 2014
Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.
FDA Recall
Terminated
·Blue Belt Technologies MN·Product code KKX·July 19, 2013
Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis.
FDA Recall
Terminated
·Blue Belt Technologies MN·Product code HSX·June 4, 2014
Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
FDA Recall
Terminated
·Blue Belt Technologies MN·Product code HSX·June 4, 2014
Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume syringe (30 cc). The manually operation of the DOLPHIN is achieved by the manipulation of a large handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device. Instantaneous deflation, regardless of balloon size, is made possible by the release of the dual locks located on device as well as a large, 30 cc syringe that is sold with each Dolphin Inflation Device. All the while during inflation or deflation pressure is displayed and can be monitored on a large analog gauge mounted on top of the device.
FDA Recall
Terminated
·Vascular Solutions, Inc.·Product code MAV·April 12, 2017
Merit Inflation Syringe Kit. Catalog Number KOS-02857
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code MAV·August 25, 2016
Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20bars in 0.5 bar increments. The Everest 30atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 30bars in 0.5 bar increments. The manometers are accurate to within +/- 3% of the gauges full scale. The device is a sterile, single use device and is not implanted; it also does not come in direct contact with the patient. This product is packaged in an inner and outer Tyvek /poly layer pouch.
FDA Recall
Terminated
·Medtronic Vascular·Product code MAV·February 6, 2014
Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components, intended for both primary and revision applications. Indications: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis when one or more compartments are involved, 2) correction of varus, valgus, or posttraumatic deformity, 3) correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure
FDA Recall
Terminated
·Biomet, Inc.·Product code MBV·November 15, 2012
Viceroy Inflation Syringe, 60mL, without gauge.
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code MAV·October 21, 2005
IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface 10m cable
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code MAV·November 7, 2005