86 results
·
15ms
·
Sources: EU EUDAMED, US FDA
THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.
FDA Enforcement
Class II
·Terminated·Lansinoh Laboratories Inc·February 13, 2013
KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired
FDA Enforcement
Class II
·Terminated·KT Health, LLC·April 29, 2020
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
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.
FDA Enforcement
Class II
·Terminated·Med-Hot Thermal Imaging, Inc.·May 17, 2017
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
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