BEUDAMED
    18 results · 20ms · Sources: EU EUDAMED, US FDA

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    PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587T1512280·15mm TLIF Implant 12mm Wide 28mm Length

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·14026704629760·MICHEL CLIPS 18 MILLIMETER100/PACK

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158212572·FORCEPS TENACULUM HULKA 11"

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587T15122870·15mm TLIF Implant 12mm Wide 28mm Length 7 Degrees

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869607667·TELIX K Ti Cage 12x28mm 5°

    BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MIRADA XD

    FDA 510(k)
    FDA Class 2 ·Radiology

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013

    AUGMENTED INSERT

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code KWA·June 30, 2011

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.

    FDA Enforcement
    Class II ·Terminated·Cardiovascular Systems Inc·May 31, 2017

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    Medical Linear Accelerator

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 14, 2016

    dS Breast 16ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024