46 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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CURAD REUSABLE GEL HOT/COLD PACK
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 16, 2022
Artis zee biplane MN, Model Number 10094143
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis zee floor MN, Model Number 10094142
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 5, 2025
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 5, 2025
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 5, 2025
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 5, 2025
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 5, 2025
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 5, 2025
Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·November 16, 2022
Artis Q.zen floor, Model Number 10848353
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis Q zeego, Model Number 10848283
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis Q.zen biplane, Model Number 10848355
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·February 11, 2026
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·February 11, 2026
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·February 11, 2026
Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·November 16, 2022
Artis Q floor, Model Number 10848280
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis Q.zen ceiling, Model Number 10848354
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
FDA Enforcement
Class II
·Ongoing·Augustine Temperature Management, LLC·February 26, 2025