BEUDAMED
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    Versana Active

    FDA 510(k)
    FDA Class 2 ·Radiology

    HHM

    FDA UDI
    Oticon A/S·05707131349989·G500 S, BTE PP 13 2.4G 105 C090 HHM

    OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    200996-Cable Assembly, Hybrid Extended Length, 200997 Cable Assembly, Hybrid, Guidance Module, 200998 Cable Assembly, Hybrid, UI Panel Subcomponents for the 203000 RIO STANDARD SYSTEM Manufactured by: MAKO Surgical, Corp. Fort Lauderdale, FL. All three cables are integral components and are not purchased separately. However, 200996-Cable Assembly is the only cable visible. This cable is labeled: 200996-REV-1, KSM 390634-1, SN 000001. 200997 and 200998 Cable Assembly are not visible . The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code HAW·July 17, 2009

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·October 27, 2014

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 11, 2011

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 2, 2013

    Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021