123 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code 66145; c) STERILE STRT KELLY HEMOSTAT (SK8039), Product Code 66170; d) STERILE CURV KELLY HEMOSTAT (CK8040), Product Code 66175; e) STERILE CURV SATIN HEMOSTAT (MHS103S), Product Code 66445; f) STERILE STRT SATIN HEMOSTAT (MHS102S), Product Code 66485; g) STERILE STRT KELLY HEMOSTAT (SK8039S), Product Code 66695; h) STERILE STRAIGHT KELLY HEMOSTAT, Product Code 67140; i) ST. STR MOSQUITO HEMOSTAT 3 1/2"(MHB700), Product Code 67325; j) STERILE CVD MOSQT HEMOST 3 1/2"(MHB710), Product Code 67330; k) STERILE 8" CRVD KELLY HEMOSTAT (CK1008), Product Code 67655; l) STERILE 8" STR KELLY HEMOSTAT (SK1008), Product Code 67660; m) ST MOSQUITO HEMO CURVED FINE PT (P/S), Product Code I68100; n) ST CURVED KELLY HEMOSTAT-TAMPA GEN, Product Code I68310; o) STERILE STRT KELLY HEMOSTAT (ZM-09417), Product Code P-65240; p) STERILE STRT MOSQUITO HEMOSTAT (MHS102), Product Code TRI66140; q) STERILE CURVED KELLY HEMO (ST153), Product Code TRI66765
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 10, 2024
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