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

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    EnsoSleep

    FDA 510(k)
    FDA Class 2 ·Neurology

    Trinity Acetabular Hip System

    FDA UDI
    CORIN LTD·05055343896112·CoCr Liner Impactor Head (Size 2)

    MEDI

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

    24M - Safety General Purpose

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588100340·24M - Safety General Purpose

    Implant, Resorbable, For Articular Osteochondral Repair

    FDA Pre-Market Approval
    FDA Class 3 ·Agili-C

    NA

    FDA UDI
    STRYKER CORPORATION·04546540144201·Medium Soft Cone Splash Shield

    DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RADIOGRAPHIC X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Implant, Resorbable, For Articular Osteochondral Repair

    FDA Pre-Market Approval
    FDA Class 3 ·Agili-C

    ADMIRAL

    FDA Adverse Event
    Malfunction ·SEASPINE ORTHOPEDICS CORPORATION·Product code KWQ·March 28, 2025

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 46MM

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code HWC·November 10, 2016

    VERSAPORT V2 FIXATION CANNULA 5MM

    FDA Adverse Event
    Malfunction ·PONCE-USS·Product code GCJ·October 21, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 8, 2013

    AFX

    FDA Adverse Event
    Injury ·ENDOLOGIX INC.·Product code MIH·May 29, 2018

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023

    Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    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 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