224 results
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14ms
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Sources: EU EUDAMED, US FDA
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a tabletop or with a floor stand. The DxH 600 is available as an analyzer for use on a tabletop only.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·November 13, 2013
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a benchtop or with a floor stand. The DxH 600 is available as an analyzer for use on a benchtop only.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·December 23, 2015
UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a benchtop or with a floor stand. The DxH 600 is available as an analyzer for use on a benchtop only.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·December 23, 2015
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2020
Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 30, 2020
RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product.
FDA Enforcement
Class II
·Terminated·Roche Diabetes Care, Inc.·May 4, 2022
Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.
FDA Enforcement
Class II
·Terminated·Arjo Hospital Equipment AB·March 18, 2015
Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion brand name.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·December 17, 2014
Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.
FDA Enforcement
Class III
·Terminated·Randox Laboratories·June 7, 2017
Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES, LP - Northfield·April 13, 2022
Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments brand name.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·December 17, 2014
Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·December 17, 2014
Proteus 235 Proton Therapy System for cancer treatment.
FDA Enforcement
Class II
·Terminated·Ion Beam Applications S.A.·November 5, 2014
Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.
FDA Enforcement
Class II
·Terminated·Ormco/Sybronendo·April 9, 2014
Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·December 17, 2014
McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·December 17, 2014
Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·December 17, 2014
Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·January 9, 2013
D'errico perforator drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Teleflex Medical, and CareFusion brand names.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·December 17, 2014
Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer.
FDA Enforcement
Class II
·Terminated·Envoy Medical Corporation·February 6, 2013