BEUDAMED
    15 results · 82ms · Sources: EU EUDAMED, US FDA

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    EC-5000CXIII

    FDA Adverse Event
    Malfunction ·NIDEK INCORPORATED·Product code HQF·November 7, 2016

    The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.

    FDA Enforcement
    Class II ·Terminated·PhotoMedex, Inc.·October 9, 2013

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MIH·October 19, 2016

    DEXCOM G6

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·December 22, 2025

    PUMP MMT-1780X 670G MILLIGRAM

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 25, 2021

    PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code NRY·August 27, 2025

    PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code NRY·August 27, 2025

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    FDA Adverse Event
    Malfunction ·BOLTON MEDICAL, INC.·Product code MIH·December 28, 2023

    O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000

    FDA Recall
    Terminated ·O-Two Medical Technologies, Inc.·Product code BZR·May 14, 2018

    Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is used for the delivery of inhaled nitric oxide to patient. An INOmeter is affixed to each cylinder of drug product. Functionality of the INOmeter: The INOmeter is affixed on top of each INOflo cylinder valve in Japan. When the healthcare provider opens the INOmeter the compressed gas cylinder valve opens to begin flow of the nitric oxide in nitrogen compressed gas. The nitric oxide gas is administered to a patient via a nitric oxide delivery device. The amount of time that gas flow administered to a patient is captured in the INOmeter. Each INOmeter is programmed to include the drug product expiration date as listed on the INOflo drug product label. The INOmeter electronically communicates to the nitric oxide delivery device via infrared technology by way of the iButton and in so communicates the expiration date of the corresponding cylinder of INOflo drug product to the delivery device. The delivery device evaluates and compares the expiration date to the current date of therapy administration. If the drug product expiration date is prior to the current date, an error and alarm is registered by the nitric oxide delivery device and administration of the expired drug to the patient is stopped after 120 seconds. If this occurs, the healthcare provider can operate the nitric oxide delivery device manually and deliver the INOflo as indicated in the Instructions For Use (IFU). The INOflo delivery device has the functionality to administer INOflo in manual mode.

    FDA Recall
    Terminated ·INO therapeutics LLC/dba ikaria·Product code MRN·July 9, 2018

    NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream Health, Inc., Rochester, NY. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.

    FDA Recall
    Terminated ·NOVADAQ TECHNOLOGIES INC.·Product code MMP·June 27, 2017

    The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.

    FDA Recall
    Terminated ·PhotoMedex, Inc.·Product code GEX·January 4, 2013

    NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, Rx.. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.

    FDA Recall
    Terminated ·NOVADAQ TECHNOLOGIES INC.·Product code MMP·June 27, 2017

    NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), Sterile, Rx. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.

    FDA Recall
    Terminated ·NOVADAQ TECHNOLOGIES INC.·Product code MMP·June 27, 2017

    Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

    FDA Recall
    Terminated ·Penumbra Inc.·Product code NRY·December 15, 2020