1,810 results
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Sources: EU EUDAMED, US FDA
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The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.
FDA Enforcement
Class II
·Ongoing·Ithera Medical Gmbh·February 19, 2025
Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for children aged 1-8, The GoTo Seat is a light-weight, portable, postural support seat for kids, aged between 1 and 8 with disabilities.
FDA Enforcement
Class II
·Ongoing·James Leckey Design Ltd·April 15, 2020
EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a medical device that detects the presence of the SmartClip Soft Tissue Marker(s) and provides real-time three-dimensional navigation during surgery.
FDA Enforcement
Class II
·Ongoing·Elucent Medical Inc·January 15, 2025
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
FDA Enforcement
Class I
·Ongoing·Abbott·July 19, 2023
Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.
FDA Enforcement
Class II
·Ongoing·Securitas Healthcare LLC·July 31, 2024
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 12, 2022
Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in one liter bag with 4 units per carton box. Celsior shall be stored between 36¿ to 46¿F. In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).
FDA Enforcement
Class II
·Ongoing·INSTITUT GEORGES LOPEZ·August 6, 2025
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
FDA Enforcement
Class II
·Ongoing·Elekta Instrument AB·May 29, 2019
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
FDA Enforcement
Class I
·Ongoing·Maquet Medical Systems USA·December 13, 2023
VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·May 25, 2022
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
FDA Enforcement
Class II
·Ongoing·New Standard Device Inc·June 21, 2023
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·July 9, 2025
TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.
FDA Enforcement
Class II
·Ongoing·Limacorporate S.p.A·January 1, 2025
Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
FDA Enforcement
Class III
·Ongoing·Abbott Molecular, Inc.·March 6, 2024
Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resident living areas to allow immediate staff response.
FDA Enforcement
Class II
·Ongoing·Securitas Healthcare LLC·July 31, 2024
Impella LD intravascular micro axial blood pump, Product Number 005082
FDA Enforcement
Class I
·Ongoing·Abiomed, Inc.·July 26, 2023
Impella 2.5 intravascular micro axial blood pump, Product Number 005042
FDA Enforcement
Class I
·Ongoing·Abiomed, Inc.·July 26, 2023
Impella 5.0 intravascular micro axial blood pump, Product Number 005062
FDA Enforcement
Class I
·Ongoing·Abiomed, Inc.·July 26, 2023
Impella CP intravascular micro axial blood pump, Product Number 0048-0032
FDA Enforcement
Class I
·Ongoing·Abiomed, Inc.·July 26, 2023
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·November 9, 2022