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

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    Omnispec ED1000

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Hysteroscopic Roller Base

    FDA UDI
    Smith & Nephew, Inc.·03596010529558·HYST. FLUID MGMT ROLLER BASE

    VERSALOOP™ Anchor 1 Tape, 1.5mm

    FDA UDI
    T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION·10818674024768·

    Dilator, Vascular, acc. Garrett 35cm 3.0mm

    FDA UDI
    Geister Medizintechnik GmbH·04057034047552·Dilator, Vascular, acc. Garrett 35cm 3...

    InterPulse

    FDA UDI
    STRYKER CORPORATION·04546540861856·with Suction, High Flow Tip and Dual-Spike Adaptor

    CLEARCUT S SAFETY KNIFE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology

    GALAXY G3 MINI 1MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·June 19, 2020

    PLUS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPEDICS AG·Product code KWY·October 23, 2008

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·August 12, 2011

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·July 3, 2013

    GALAXY G3 MINI 1MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·October 1, 2022

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2015

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    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

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024