BEUDAMED
    16 results · 36ms · Sources: EU EUDAMED, US FDA

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    Well-life TM Pen Needles, Well-life TM Safety Pen Needles

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SOFTSILK

    FDA UDI
    Smith & Nephew, Inc.·00885554012385·MTO SOFTSILK SCREW 13MMX40MM STRL ...

    SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    OLYMPUS INSTRUMENT TRAY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 13, 2012

    TENOR SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·October 23, 2008

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    BAXTER HEALTHCARE·Product code FKX·August 12, 2011

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013

    GALAXY G3 MINI 1MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·April 20, 2021

    GALAXY G3 MINI 1MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·April 20, 2021

    GALAXY G3 MINI 2MM X 6CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 4, 2021

    GALAXY G3 MINI 1MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 4, 2021

    GALAXY G3 MINI 1MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 30, 2022

    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

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 7, 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