118 results
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6ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·September 29, 2021
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
FDA Enforcement
Class II
·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·December 24, 2014
Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc arthrodesis, Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·August 8, 2012
GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
FDA Enforcement
Class II
·Ongoing·GRAMERCY EXTREMITY ORTHOPEDICS·April 26, 2023
CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST
FDA Enforcement
Class II
·Ongoing·Carefusion 2200 Inc·November 23, 2022
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
FDA Enforcement
Class II
·Ongoing·Treace Medical Concepts, Inc.·September 4, 2024
CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST
FDA Enforcement
Class II
·Ongoing·Carefusion 2200 Inc·November 23, 2022
CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-3ST
FDA Enforcement
Class II
·Ongoing·Carefusion 2200 Inc·November 23, 2022
BD Pyxis Mini Main REF: 349 Medication cabinet
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·June 10, 2026
BD Pyxis MedStation ES REF: 323 Medication cabinet
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·June 10, 2026
BD Pyxis MedStation 4000 REF: 303 Medication cabinet
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·June 10, 2026
BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·June 10, 2026
BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·June 10, 2026
BD Pyxis MedStation ES Tower REF: 352 Medication cabinet
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·June 10, 2026
BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·June 10, 2026
BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·June 10, 2026
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·January 6, 2021
Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 6, 2014
Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
FDA Enforcement
Class II
·Terminated·Helena Laboratories, Inc.·September 11, 2019
Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during endocosopic therapy by manipulating colonic folds
FDA Enforcement
Class II
·Terminated·Boddingtons Plastics Ltd·April 22, 2020