19 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Plum Duo Infusion Pump, 40002-0401
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·June 17, 2026
Plum Duo Precision IV Pump, 40002-0403
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·June 17, 2026
Plum Solo Precision IV Pump, 40001-0401
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·June 17, 2026
6IN PRESSURE TUBING, List Number MX20617
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024
Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024
HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024
Medex LOGICAL CATH LAB KIT, List Number M20754
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024
20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R
FDA Enforcement
Class II
·Ongoing·Smiths Medical Asd Inc·January 24, 2024
Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.
FDA Enforcement
Class II
·Terminated·Sekisui Diagnostics P.E.I. Inc.·March 23, 2016
CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level allows the bowl to be tilted up to approximately 10¿ in relation to the baseplate at infinite intervals. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can immobilize the patient to under 1 millimeter. The provider can correct the patient position for simulation and treatments by tilting the device.
FDA Enforcement
Class II
·Terminated·Med Tec Inc·June 26, 2019
AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·February 6, 2013
Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
FDA Enforcement
Class II
·Terminated·Ion Beam Applications S.A.·May 2, 2018
MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
FDA Enforcement
Class II
·Terminated·Medrad Inc dba Bayer R&I·June 3, 2015
enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Track System -- NOTE: Outside the US the system is also known as VITROS Automation Solution (VAS) TC Automation System (configured with Thermo Scientific Recapper Module from VITROS Automation Solutions), Product Code 6844300 --- The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TC Automation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. The enGen (TM) Laboratory Automation System contains a module (i.e. enGen (TM)Laboratory Automation Recapper Module) that applies caps to the sample collection container after the sample has been aspirated. In this module, an electrical cable supplies power to the cap vibratory feeder and is supposed to be located above the vibratory feeder support plate. The cap vibratory feeder sits upon a feeder support plate. Un-capped sample containers pass underneath this support plate prior to being re-capped for storage. The Recapper Module is supplied by Thermo Fisher Scientific.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·May 4, 2016
Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·October 3, 2012