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

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Mok Eye Pack, Kit number PSS2640 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas. Hem-o-lok Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·March 2, 2016

    T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting bone and/or bone marrow specimens

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·February 22, 2017

    Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: - An empty plastic syringe with Luer-Lok" tip - A plastic syringe with Luer-Lok" tip containing the Flowable Wound Matrix material - A syringe-to-syringe Luer-Lok" adapter / connector - A flexible plastic tube (injector) with Luer-Lok" connector Instructions for Use (IFU) and the sterilized package are subsequently packaged in a labeled and sealed box that is distributed to customers.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·April 22, 2015

    T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·July 29, 2015

    Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. Teleflex Medicals Hem-o-lok polymer ligating clips are single use, sterile, non-absorbable medial devices that have been designed to ligate vessels and tissue structures during various types of surgical procedures. Vessels and tissue structures in the range of 0.5 to 16 mm can be effectively ligated with Hem-o-lok clips.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·October 24, 2012

    3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·July 31, 2019

    3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·July 31, 2019

    *** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: List No. 19685-28; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML; *** 3) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3 CLAVE PORTS,IN LINE CHECK VAL OPTION LOK, NON-DEHP.; NOMINAL LENGTH:145 IN (368 CM); PRIMING VOLUME:13 ML; *** 4) Product labeled in part: 19721-28; LIFESHIELD; SOLUSET 150ML BUR,CONV P.P DUAL CHANNEL 4 CLAVE PORTS IN LINE CHECK VAL OPTION LOK, NON-DEHP; NOMINAL LENGTH: 145 IN (368 CM); PRIMING VOLUME: 15 ML: *** 5) Product labeled in part: 19729-28; LIFESHIELD; CONV. DUAL CHANNEL PLUMSET WITH CLAVES, AND SECURE LOK, NON-DEHP; NOMINAL LENGTH: 96 IN (244 CM); PRIMING VOLUME: 18 ML; *** 6) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·July 6, 2016

    8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·December 3, 2014

    RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant

    FDA Enforcement
    Class II ·Terminated·BioHorizons Implant Systems Inc·December 16, 2015

    BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·July 26, 2017

    WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·November 15, 2017

    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

    Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671

    FDA Enforcement
    Class II ·Terminated·C.R. Bard, Inc.·April 8, 2015

    DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment, support, and rehabilitation of many types of knee injuries or following surgical correction.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·May 21, 2014

    Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·May 7, 2014

    BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·July 26, 2017

    BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·July 26, 2017

    BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·July 26, 2017