228 results
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23ms
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Sources: EU EUDAMED, US FDA
Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQO·January 14, 2004
Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System. Material Number (UPN) M001553030, Catalog Number 55-303. [OUS Material Number (UPN) M001553000, Catalog Number 55-300]
FDA Recall
Terminated
·Boston Scientific Corporation·Product code NIM·June 6, 2008
Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound System; Catalog Numbers: 23656 (New), 45441 (Refurb)
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code MAA·March 31, 2003
Product is a handheld fetal Doppler used to screen for fetal heart rate and averaged fetal heart rate and is labeled as: Sonotrax Handheld Fetal Doppler Series and includes the Basic and Lite models.
FDA Recall
Terminated
·Danatech Medical Systems Inc·Product code MAA·December 5, 2003
Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound System; Catalog Numbers: 23656 (New), 45441 (Refurb)
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code MAA·March 31, 2003
DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED). The DDC-6-AA data card is an accessory to the AED and does not have its own intended use.
FDA Recall
Terminated
·Defibtech, LLC·Product code MKJ·August 27, 2010
Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc., Adel, IA. The product is sold individually or in master packs of 8 under the following model numbers (all using the same box label): Model 7000 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; Model 7030 - Consisting of the Aeroneb Go, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7070 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7000-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, European mask elbow, mouthpiece, carry bag, and user manual; Model 7030-1 - Consisting of the Aeroneb Go, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual; Model 7070-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual. 7000LINCARE - Consisting of the Aeroneb Go, battery controller with a Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; 7070LINCARE - Consisting of the Aeroneb Go, battery controller with the Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual.
FDA Recall
Terminated
·Medical Industries America Inc·Product code CAF·September 7, 2004
3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.
FDA Recall
Terminated
·Mindray DS USA, Inc. dba Mindray North America·Product code MSX·May 27, 2021
Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the ARROWg+ard Blue PLUS catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied.
FDA Recall
Terminated
·Arrow International Inc·Product code FOZ·July 18, 2019
Health o Meter Professional Remote Display Digital Physician Scale, Model 498KL; digital patient weighing scale; Pelstar LLC, 11800 South Austin Avenue, Unit B, Alsip, IL 60803, U.S.A., Made n China; Model 498KL Model 498KL scale with remote display head uses sophisticated microprocessor technology. Each instrument is designed to provide accurate, reliable and repeatable weight measurements and features that make the weighing process simple, fast and convenient. The scale is set up to determine the weight of a stationary patient. The weight can be displayed in pounds or kilograms. The unit can be operated by an AC adaptor (optional) or by 6-AA cell batteries (included).
FDA Recall
Terminated
·Pelstar, Llc·Product code FRI·October 7, 2011
OEC 9800MD Motorized C-arm System, Fluoroscopic X-ray System,
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·February 9, 2007
OEC 9800 Fluoroscopic X-ray System, Model Number A349855, GE Healthcare, Surgery.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·February 9, 2007
Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code JAA·April 16, 2009
Philips Verardius Image Intensified X-ray Catalog Number: 718130 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code JAA·October 4, 2011
Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
FDA Recall
Terminated
·Hologic, Inc.·Product code JAA·September 14, 2012
NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·April 10, 2008
GE OEC 9900 Elite ESP fluoroscopic x-ray system. GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy.
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code JAA·August 29, 2008
Digital Radiography System Model DFP-8000D/FPD,
FDA Recall
Terminated
·Toshiba American Med Sys Inc·Product code JAA·November 10, 2005
GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·July 6, 2007
GE OEC 6800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·June 12, 2007