BEUDAMED
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    POWDERED VINYL EXAM GLOVES, WHITE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    IMPACT-20

    FDA UDI
    Denplus Inc·D8451031104·IMPACT-20, SPI, 454 g

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00311041·

    Curette

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102114·SHEPHERD CAPSULE POLISHER RIGHT

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0310040·Probe, 1.5 inch Ball, Lenke, Straight, Black

    OSTEOBELL

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

    SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·March 17, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·April 17, 2008

    ARTEGRAFT COLLAGEN VASCULAR GRAFT

    FDA Adverse Event
    Injury ·ARTEGRAFT, INC.·Product code LXA·July 3, 2006

    Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042).

    FDA Recall
    Terminated ·Heartport Inc Route·Product code DWF·October 2, 2003

    Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona¿ Personalized Knee System.

    FDA Enforcement
    Class II ·Ongoing·Canary Medical, Inc.·July 16, 2025

    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

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016