BEUDAMED
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    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

    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

    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

    OPMI Pentero, OPMI Pentero C, OPMI Pentero 900, OPMI Vario/S8, OPMI Vario/S88, OPMI Neuro Multivision/NC4, OPMI Vario/NC33, OPMI Neuro/NC4, OPMI Neuro/NC4 Ceiling Mount. A surgical microscope and accessories is an AC powered device intended for use during surgery to provide a magnified view of the surgical area.

    FDA Recall
    Terminated ·Carl Zeiss Meditec, Inc.·Product code EPT·September 12, 2011

    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

    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

    Alkaline Phosphatase Substrate Mfg. for Alfa Wassermann Diagnostic Technologies LLC, Caldwell, N.J. in 2.1 mL and 7.5mL containers. In vitro diagnostic.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CJE·June 9, 2006

    Alkaline Phosphatase Buffer Mfg. for Alfa Wassermann Diagnostic Technologies LLC, Caldwell, N.J. in 8.4 mL and 30 mL containers. In vitro diagnostic.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CJE·June 9, 2006

    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

    ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a ''Stapler, reload, TR35W, TR776, TCR 75, TCR 55, TRT75,

    FDA Recall
    Terminated ·International Surgical Supply, Inc.·Product code KDC·September 3, 2003

    ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Stapler EMS Endo Hernia , item # 8034.

    FDA Recall
    Terminated ·International Surgical Supply, Inc.·Product code KDC·September 3, 2003