BEUDAMED
    19 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·July 11, 2018

    COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·April 15, 2026

    StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip (Model 0250070520) STRYKER LAPAROSCOPIC SUCTION IRRIGATOR

    FDA Enforcement
    Class II ·Terminated·Stryker Corporation·March 14, 2018

    Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neurosurgery·July 26, 2023

    NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205 0202261207 0202261209 0202261213 0202261305 0202261307 0202261309 0202261313

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·November 13, 2019

    NCB¿-PH Plate

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·November 14, 2012

    NCB¿ cancellous screw

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·November 14, 2012

    NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009 0202263012 0202263015 0202263018 0202263021 0202263109 0202263112 0202263115 0202263118 0202263121 0202264009 0202264012 0202264015 0202264018 0202264021 0202264109 0202264112 0202264115 0202264118 0202264121 0202265010 0202265012 0202265014

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·November 13, 2019

    The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These screws are intended for bicortical anchorage.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 22, 2012

    NCB¿ screw ¿ 4.0 self-tapping

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·November 14, 2012

    NCB¿-PT lateral proximal 3 hole tibial plate

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·November 14, 2012

    Connection Screw for NCB Plate, Item No. 0202266002

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·November 13, 2019

    Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments

    FDA Enforcement
    Class II ·Ongoing·Straumann USA LLC·May 6, 2026

    NCB-PH Plate with 4/5/7 Lock Holes, Item Nos. 0202262104 0202262105 0202262107

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·November 13, 2019

    cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·November 13, 2019

    NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0202267012 0202267014 0202267016 0202267018

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·November 13, 2019

    Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments

    FDA Enforcement
    Class II ·Ongoing·Straumann USA LLC·May 6, 2026

    NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 4.5 mm Diameter 195 mm Length, Item Number/EDI 0200024330, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 3.5 mm Diameter 195 mm Length, Item Number/EDI 0200024325, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017