34 results · 77ms · Sources: EU EUDAMED, US FDA

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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