BEUDAMED
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    BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04047872673174·LEVAMED STABILI-TRI ANK BLU R I

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040056455·Zirlux Multi Anterior B1,98.5X20

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04047872673136·LEVAMED STABILI-TRI ANK SUP BLU L I

    G-aenial™

    FDA UDI
    Gc America Inc.·D0470123511·G-aenial Univ. Injectable Unitip A3.5

    ACS HI-TORQUE GUIDE WIRE

    FDA Adverse Event
    Injury ·GUIDANT, ADVANCED CARDIOVASCULAR SYSTEMS·Product code DQX·February 13, 2002

    FLUOROTEX II SURGICAL MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HTJ·February 3, 2025

    AGILTRAC .035 PERIPHERAL DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code LIT·August 25, 2008

    DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HTJ·February 6, 2025

    T-SLING

    FDA Adverse Event
    Injury ·HERNIAMESH S.R.L.·Product code PAH·March 7, 2013

    SAFE-T-PRO PLUS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·March 9, 2011

    CHARITE ARTIFICIAL DISC, SIZE UNK

    FDA Adverse Event
    Injury ·DEPUY SPINE, INC.·Product code MJO·February 12, 2008

    ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 7, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019