BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    One Touch Spiral Condom

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777518·LUMBAMED PLUS FLEX PAD M SILVER IV

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777464·LUMBAMED PLUS FLEX PAD WM SILVER IV

    TWINFIX / DURABRAID

    FDA UDI
    Smith & Nephew, Inc.·03596010533838·TWINFXTI2.8 STR ANCHR W/DURBRD STR 2-0

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010422071·INGE LAMINA SPREADER 9.5MM WIDE

    Radius Plate PROlock G

    FDA UDI
    I.T.S. GmbH·09120047296868·Radius Plate PROlock G, 4-Hole, Right

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 1, 2022

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 23, 2022

    GrandioSO Light Flow

    FDA 510(k)
    FDA Class 2 ·Dental

    HIGH FLOW INSUFFLATION UNIT UHI-4

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2024

    TRUE METRIX AIR

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·June 4, 2020

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 29, 2014

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 27, 2013

    TERUMO CDI 540 CALIBRATOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·August 8, 2011

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015