BEUDAMED
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    M2A 32MM TAPER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROSTHESIS, HIP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWY·November 11, 2021

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099853·MN 2ND BI BD KT N/L UNIV 123

    Premier Elevator

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783004076·ELEVATOR 304 B

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085022833·SAF Fixative 50 vials

    MEDOVATIONS ESOPHAGEAL DILATOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 3

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code HSX·February 3, 2017

    MESH - COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC.·Product code FTL·June 14, 2011

    DEXTRUS 4136

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·February 13, 2013

    COLLEAGUE COLOR PUMP CE FRENCHVERSION SINGLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 1, 2011

    SELUTE PICOTIP

    FDA Adverse Event
    Death ·CARDIAC PACEMAKERS, INC., GUIDANT PUERTO RICO B.V.·Product code DTB·February 15, 2008

    smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024