14 results
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10ms
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Sources: EU EUDAMED, US FDA
EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
FDA Enforcement
Class II
·Ongoing·Encore Medical, Lp·December 18, 2019
Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body.
FDA Enforcement
Class II
·Terminated·Thermo Finnigan LLC·September 21, 2016
PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
FDA Enforcement
Class II
·Ongoing·Ethicon Endo Surgery, LLC·April 9, 2025
RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752. This product is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.
FDA Enforcement
Class II
·Terminated·Eizo Corporation·July 22, 2015
Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time oblique imaging, Integrated image fusion, JPEG2000-based Adaptive Bandwidth Streaming, JPEG and Key Image Note export, Presentation States, Annotation and measurement tools, Automated linking, Display protocols, Enterprise Worklist, prior study management, softcopy viewing of digital mammography images provided that only 5 MP monitors with a cleared 510(k) are used and that digitized secondary captures of these images are not viewed for assisting in diagnosis, utilization of thirdparty electronic orthopedic templates, the display of Standard Uptake Value, recording voice reports using third party, plug-in software, and user configurable settings for viewing digital medical images and corresponding data The application provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. The system displays traditional 2D and reconstructed 3D radiological images using Webenabled viewers over both local and wide area networks. The application provides workflow integration capabilities for health care enterprises, wherein: ¿ Radiologists can view, annotate, and tag studies as diagnostically Read. ¿ Referring physicians can view patient images and radiologists annotations. ¿ Tertiary care physicians, medical technologists, and information technology professionals can receive patient records.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·November 30, 2016
Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
FDA Enforcement
Class II
·Ongoing·EMD Millipore Corporation·March 6, 2024
Lugol s Iodine Solution 500ML, Part Number 624-71
FDA Enforcement
Class II
·Ongoing·EMD Millipore Corporation·December 6, 2023
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325 cc), Part No. 3748 3) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, 1 Quart (946 cc), P/N 3306 4) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid PN 7450, 5) ThermoFlex ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS 1 Quart (946 cc) P/N 7465 Indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base
FDA Enforcement
Class II
·Terminated·CMP Industries, Llc·July 6, 2016
IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface
FDA Enforcement
Class II
·Terminated·CMP Industries, Llc·July 6, 2016
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML), REF 3748, Rx ONLY, 3) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid, PN 7450; Indicated for relining a denture surface.
FDA Enforcement
Class II
·Terminated·CMP Industries, Llc·July 6, 2016
IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. Indicated for relining a denture surface for repairing a fractured denture, or forming a new denture base.
FDA Enforcement
Class II
·Terminated·CMP Industries, Llc·March 16, 2016
IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards
FDA Enforcement
Class II
·Terminated·CMP Industries, Llc·November 7, 2018
Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF: 3748GB. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards
FDA Enforcement
Class II
·Terminated·CMP Industries, Llc·November 7, 2018
Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.
FDA Enforcement
Class II
·Terminated·EMG Technology Co., Ltd.·September 24, 2014