BEUDAMED
    22 results · 21ms · Sources: EU EUDAMED, US FDA

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    SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).

    FDA Enforcement
    Class II ·Terminated·Sarken, Inc.·September 4, 2013

    Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·December 24, 2014

    CareLink Clinic, REF: MMT-7350

    FDA Enforcement
    Class II ·Ongoing·Medtronic MiniMed, Inc.·December 3, 2025

    TLC-2000 Therapeutic Medical Laser System

    FDA Enforcement
    Class III ·Terminated·Theralase Inc.·February 26, 2020

    Assayed Bovine Multi-Sera Level 1, Model No. AL1027

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories, Limited·August 14, 2019

    PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·November 6, 2013

    Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)

    FDA Enforcement
    Class II ·Ongoing·Nova Ortho-Med Inc·December 30, 2020

    MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086

    FDA Enforcement
    Class II ·Terminated·Impac Medical Systems Inc·July 18, 2012

    TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.

    FDA Enforcement
    Class III ·Terminated·Theralase Inc.·February 26, 2020

    Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 701043292

    FDA Enforcement
    Class III ·Terminated·Maquet Cardiovascular Us Sales, Llc·September 23, 2020

    a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests. Model Number: 5002. b. McKesson Consult Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Urine Sample 25 Tests Model Number: 5000. c. McKesson Medical-Surgical McKesson TEST KIT, PREG HCG CASSETTE WAIVED Model Number: 5001

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022

    "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the graphic user interface, which is loaded onto the linkstations.

    FDA Enforcement
    Class II ·Terminated·Orthosensor·October 31, 2012

    Astral 100 and Astral 150 ventilators

    FDA Enforcement
    Class I ·Ongoing·ResMed Ltd.·November 1, 2023

    Philips HeartStart FRx AED.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corp.·May 30, 2018

    Philips HeartStart (HS1) Onsite/Home AED

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corp.·May 30, 2018

    The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfecting, and drying of carts, utensils, beds and other miscellaneous reusable items used in the care of patients at healthcare facilities / Crated for shipping.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·August 8, 2012

    Hintermann Series Talar Implant, Left, Size 2 REF 302112

    FDA Enforcement
    Class II ·Ongoing·DT MedTech, LLC·June 17, 2026

    DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.

    FDA Enforcement
    Class II ·Terminated·DT MedTech, LLC·November 14, 2018

    DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.

    FDA Enforcement
    Class II ·Terminated·DT MedTech, LLC·November 14, 2018

    CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/* Lot Number Label: BODYGUARD LOT 2019-0364 Manufacturing Date: 2019 - 11-01 , LABEL I.D. SM-0642 REV. 01, CMEAmerica Wall Charger Kit, REF 151-143XLP, Contents; Wall Charger, Instructions, +B101150143XLP0/$$7A23456/16D000112010, Manufactured By: CME America LLC, 14988 W. 6th Ave., Suite 830, Golden. CO 80401, USA, SM-0706 Rev 00 External Charger INPUT ; AC 100-240V, 50-60Hz; 10W, 0.3A max., OUTPUT: DC 8.4V, 300mA/DC 9V, 800mA, CME America, LLC , Label ID: SM-0718, Rev. 00 Label, Wall Mount Charger, Pump Service: Use with CME Pumps & Accessories ONLY. Refer Servicing to Qualified Personnel., LABEL I.D. : SM-0756 REV 00

    FDA Enforcement
    Class II ·Terminated·CME America LLC·November 4, 2020