BEUDAMED
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    COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL

    FDA 510(k)
    FDA Class 1 ·General Hospital

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002064·artVeneer life upper posteriors, M, B2

    MAMMARY PROSTHESIS

    FDA Adverse Event
    DOW CORNING CORP.·Product code FTR·May 18, 1994

    PERSONA™ Trabecular Metal™

    FDA UDI
    Zimmer, Inc.·00889024229051·

    Persona® Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024469716·

    PERSONA™ Trabecular Metal™

    FDA UDI
    Zimmer, Inc.·00889024229068·

    Persona® Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024469723·

    ZYBIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BEHRING COAGULATION TIMER ANALYZER (BCT)

    FDA 510(k)
    FDA Class 2 ·Hematology

    STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·March 13, 2013

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 28, 2011

    FAST-CATH RAMP HEMOSTASIS INTRODUCER, 8F, 60CM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL·Product code DYB·February 18, 2008

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    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

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026