BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    OEC FLUOROTRAK 9800 PLUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Safco T&F Bur - 12 Bladed

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310220693·Safco T&F bur - 12 bladed, carbide, #7902 needl...

    ASCEND SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·Neurology

    CADD MEDICATION CASSETTE RESERVOIR

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC·Product code FPA·November 7, 2024

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·October 2, 2018

    PASS LP

    FDA Adverse Event
    MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code MNI·April 5, 2012

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 26, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·February 28, 2011

    BD PARADIGM LINK GLUCOSE MONITOR

    FDA Adverse Event
    Malfunction ·NOVA BIOMEDICAL CORP.·Product code NBW·March 28, 2008

    CADD EXTENSION SET

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC·Product code FPA·November 7, 2024

    CADD EXTENSION SET WITH MALE/MALE LUER

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC·Product code FPA·January 6, 2025

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC·Product code FRN·November 7, 2024

    CADD MEDICATION CASSETTE RESERVOIR

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC·Product code FPA·January 6, 2025

    Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D 3) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA103 4) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10T 5) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10U 6) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10X 7) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10Y 8) SLH AAA PACK, Catalog Number:SCV13AASLA 9) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAF10 10) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH4 11) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH5 12) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH6 13) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH7 14) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH8 15) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH9 16) MICROVASCULAR FREE FLAP, Catalog Number:SCV30VAFHP 17) MICROVASCULAR FREE FLAP, Catalog Number:SCV30VAFHQ 18) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFHR 19) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFHS 20) NEURO EMBOLISM PACK, Catalog Number:SNE11AN102 21) NEURO EMBOLISM PACK, Catalog Number:SNE11AN10E

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·February 19, 2025

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018