122 results
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6ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897 Double Basin Set Up Kit 31145249 7897-T8 Double Basin Set Up Kit 31145298 7896-T8 Double Basin Set Up Kit 31145496 7696-T4 Single Basin Set Up Kit 31145520 7614 Single Basin Set Up Kit 31145546 7693 Single Basin Set Up Kit 31145629 7696 Single Basin Set Up Kit 31153938 7756-KST Surgical Set Up Kit 31154266 7656-KST Surgical Set Up Kit 31321097 7697 Surgical Set Up Kit 31324299 7830-HOH Surgical Set Up Kit 31451092 7600-DNV Surgical Set Up Kit 31453098 7682-MHP Surgical Set Up Kit
FDA Enforcement
Class II
·Terminated·Covidien LLC·July 29, 2015
Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
FDA Enforcement
Class II
·Terminated·Covidien LLC·November 16, 2016
Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
FDA Enforcement
Class II
·Terminated·Covidien LLC·November 16, 2016
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