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

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    catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405622 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405623 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405624 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405634 BD Spinal Anesthesia Tray 26G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405636 BD Spinal Anesthesia Tray 26G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405641 BD Spinal Anesthesia Tray 24G x 3.5 in. Sprotte¿ Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405648 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Whitacre Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog# 405649 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Whitacre Spinal Needle 25G x 3.5 in. BD" Quincke Spinal Needle Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405682 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405684 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405685 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog#405694 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405704 BD Spinal Anesthesia Tray 27G x 3.5 in. BD" Whitacre Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405737 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Whitacre Spinal Needle, TW Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) catalog# 405829 BD Spinal Anesthesia Tray 27G x 3.5 in. BD" Quincke Spinal Needle 25G x 3.5 in. BD" Whitacre Spinal Needle, TW

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·November 16, 2016

    Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016

    HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·May 24, 2017

    Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

    FDA Enforcement
    Class II ·Terminated·Southern Implants, Inc·December 4, 2013

    Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and distributed by Hospira Inc.) are placed in a separate sealed pouch. After the bone marrow biopsy pouch is sterilized, a Lidocaine pouch is affixed to each. Ten of these pouches are inserted in a sealed and labeled corrugated box.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp. d.b.a. Integra Pain Management·November 4, 2015

    Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.

    FDA Enforcement
    Class II ·Terminated·Hand Biomechanics Lab Inc·October 26, 2016

    HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·July 8, 2015

    PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101, sterile, each tray contains 5ml Ampule 1% Lidocaine HCl, 10ml Ampule 0.9% Sodium Chloride, and 5ml Ampule 1.5% Lidocaine HCl with Epinephrine 1:200,000.

    FDA Enforcement
    Class II ·Terminated·Pajunk Medical Systems, L.P.·November 30, 2022

    LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure.

    FDA Enforcement
    Class II ·Terminated·Cooper Surgical, Inc.·April 10, 2013

    Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid Profile GLU Cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are calculated by the Alere Cholestech LDX¿ Analyzer.

    FDA Enforcement
    Class II ·Terminated·Alere San Diego, Inc.·September 11, 2019

    Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Material Number (SMN): 11537213

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 6, 2023

    HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·July 8, 2015

    Dimension Assays: Direct HDL Cholesterol (AHDL)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016

    Dimension Vista Assays: Direct HDL Cholesterol (AHDL)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016

    CHOL+HDL+GLU test strips, REF 2412

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems, Inc.·May 29, 2019

    The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or venipuncture. The sample is applied to an Cholestech LDX¿ cassette. Description/Part: Cholestech LDX Lipid Profile GLU Cassette/10-991, 99021, 14-531; Cholestech LDX TC HDL GLU Cassette/10-990; Cholestech LDX Lipid Profile Cassette/10-989; Cholestech LDX TC HDL Cassette/10-987

    FDA Enforcement
    Class II ·Ongoing·Alere San Diego, Inc.·August 17, 2022

    INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp. d.b.a. Integra Pain Management·September 7, 2016

    PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems, Inc.·January 1, 2020

    ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M

    FDA Enforcement
    Class II ·Ongoing·Sklar Instruments·January 22, 2025

    Portex¿ Saddleblock Tray with Drugs  25g Quincke; 4795-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·November 13, 2013