34 results
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77ms
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Sources: EU EUDAMED, US FDA
QSENSE CPM THERMAL SENSORY ANALYZER 2001
FDA Adverse Event
Malfunction
·MEDOC LTD, ADVANCED MEDICAL SYSTEM·Product code LQW·April 19, 2022
Leckey 4-Point Pelvic Harness Belts, catalog 081326990; James Leckey Design Ltd., Kilwee Business Park, Upper Dunmurry Lane, Belfast, United Kingdom; Distributed by Patterson Medical; sold as replacement belts and as a component of the following adjustable mechanical chairs: a) Leckey Contour Advance Seat, Size 1, catalog 081117209; b) Leckey Contour Advance Seat, Size 2, catalog 081117217; c) Leckey Squiggles Saddle Seat, catalog 081326941; d) Leckey Early Sitting System, catalog 081395193
FDA Recall
Terminated
·Patterson Medical Holdings, Inc.·Product code INN·April 17, 2009
CRQ424, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company, Noblesville, IN 46060, www.kingsystems.com, 317-776-6823. Advanced Circulatory Systems, Inc., Eden Prairie, MN, www.advancedcirculatory.com, 877-7377763. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·January 14, 2011
CRQ423, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company, Noblesville, IN 46060, www.kingsystems.com, 317-776-6823. Advanced Circulatory Systems, Inc., Eden Prairie, MN, www.advancedcirculatory.com, 877-7377763. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·January 14, 2011
CRQ425, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company, Noblesville, IN 46060, www.kingsystems.com, 317-776-6823. Advanced Circulatory Systems, Inc., Eden Prairie, MN, www.advancedcirculatory.com, 877-7377763. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·January 14, 2011
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart. Including the left side of the heart through the interatrial septum.
FDA Recall
Terminated
·Greatbatch Medical·Product code DYB·September 24, 2012
Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites.
FDA Recall
Open, Classified
·Philips Medical Systems Technologies Ltd. Matam Building 8/2 Advanced Technology Center Haifa Israel·Product code LLZ·October 10, 2024
Arazy Group GmbH
Authorized representative
🇩🇪 Germany·30 Manufacturers·739 Devices
MPS Medical Product Service GmbH
Authorized representative
🇩🇪 Germany·35 Manufacturers·1959 Devices
Axxos GmbH
Authorized representative
🇩🇪 Germany·25 Manufacturers·202 Devices
AF Pharma Service Europe SL
Authorized representative
🇪🇸 Spain·51 Manufacturers·881 Devices
MedEnvoy Global BV
Authorized representative
🇳🇱 Netherlands·143 Manufacturers·2306 Devices
SOF MEDICA S.A.
Importer
🇷🇴 Romania·6 Manufacturers
mdi Europa GmbH
Authorized representative
🇩🇪 Germany·132 Manufacturers·4741 Devices
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices
Dornier MedTech Systems GmbH
Importer
🇩🇪 Germany·8 Manufacturers
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices
Medical Technology Promedt Consulting GmbH
Authorized representative
🇩🇪 Germany·194 Manufacturers·10009 Devices
Dextromedica, S.L
Importer
🇪🇸 Spain·9 Manufacturers
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices