70 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
FDA Enforcement
Class II
·Ongoing·Mint Medical GmbH·May 13, 2026
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
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
FDA Enforcement
Class II
·Ongoing·Mint Medical GmbH·December 25, 2024
mint Lesion, Software Versions: 3.10.0 and 3.10.1.
FDA Enforcement
Class II
·Ongoing·Mint Medical GmbH·December 25, 2024
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)
FDA Enforcement
Class II
·Terminated·Merete Medical GmbH·November 18, 2020
OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
FDA Enforcement
Class II
·Terminated·Merete Medical GmbH·November 18, 2020
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
FDA Enforcement
Class II
·Terminated·Merete Medical GmbH·November 18, 2020
Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
FDA Enforcement
Class II
·Terminated·Merete Medical GmbH·February 23, 2022
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
FDA Enforcement
Class II
·Terminated·Merete Medical GmbH·November 18, 2020
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
FDA Enforcement
Class II
·Completed·GELITA MEDICAL GMBH·September 28, 2022
Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6F Straight 45cm:
FDA Enforcement
Class II
·Ongoing·Contract Medical International GmbH·September 17, 2025
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
FDA Enforcement
Class II
·Ongoing·New Medical Technologies Gmbh·February 12, 2025
Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
FDA Enforcement
Class II
·Ongoing·New Medical Technologies Gmbh·February 12, 2025
TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
FDA Enforcement
Class II
·Terminated·Somatex Medical Technologies GmbH·January 31, 2018
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
FDA Enforcement
Class II
·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019
Thread-like wire marker
FDA Enforcement
Class II
·Terminated·Somatex Medical Technologies GMBH·March 17, 2021
Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
FDA Enforcement
Class II
·Ongoing·Heraeus Medical GmbH (Dental Division)·January 21, 2026
Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
FDA Enforcement
Class II
·Ongoing·Heraeus Medical GmbH (Dental Division)·January 21, 2026
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
FDA Enforcement
Class II
·Ongoing·Heraeus Medical GmbH (Dental Division)·January 21, 2026
Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
FDA Enforcement
Class II
·Ongoing·Heraeus Medical GmbH (Dental Division)·January 21, 2026