24 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Sweden
×
LoFric Origo, Tiemann, 16in, FR12 urinary catheters
FDA Enforcement
Class II
·Terminated·Wellspect HealthCare (Division of DENTSPLY IH AB)·July 29, 2020
LoFric Origo, Nelaton, 16in, FR10 urinary catheters
FDA Enforcement
Class II
·Terminated·Wellspect HealthCare (Division of DENTSPLY IH AB)·July 29, 2020
LoFric Origo, Tiemann, 16in, FR14 urinary catheters
FDA Enforcement
Class II
·Terminated·Wellspect HealthCare (Division of DENTSPLY IH AB)·July 29, 2020
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·April 9, 2014
Servo-n Ventilator System. Model Number: 6694800.
FDA Enforcement
Class I
·Ongoing·Maquet Critical Care AB·July 9, 2025
Servo-u Ventilator System. Model Number: 6688600.
FDA Enforcement
Class I
·Ongoing·Maquet Critical Care AB·July 9, 2025
Servo-u MR Ventilator System. Model Number: 6888800.
FDA Enforcement
Class I
·Ongoing·Maquet Critical Care AB·July 9, 2025
RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·April 9, 2014
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·April 30, 2014
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
FDA Enforcement
Class II
·Ongoing·Nobel Biocare·August 31, 2022
Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
FDA Enforcement
Class II
·Terminated·Getinge Disinfection·October 23, 2013
Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
FDA Enforcement
Class III
·Terminated·Getinge Disinfection Ab·August 26, 2015
Omnera 400A Digital Radiographic System
FDA Enforcement
Class II
·Ongoing·Arcoma AB·July 13, 2022
Omnera 400T Digital Radiographic System
FDA Enforcement
Class II
·Ongoing·Arcoma AB·July 13, 2022
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
FDA Enforcement
Class II
·Ongoing·Hermes Medical Solutions AB·December 18, 2024
Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.
FDA Enforcement
Class II
·Terminated·Medical Vision Ab·September 7, 2016
LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.
FDA Enforcement
Class II
·Ongoing·Jolife AB·July 2, 2025
Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not applicable
FDA Enforcement
Class II
·Ongoing·C-RAD POSITIONING AB·January 21, 2026
DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.
FDA Enforcement
Class III
·Terminated·Euro Diagnostica AB·July 5, 2017
. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function
FDA Enforcement
Class II
·Ongoing·Nobel Biocare·February 12, 2025