BEUDAMED
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    VALEO VT-601 SERIES IR THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010412362·HOKE OSTEOTOME 1.4 X 6

    JOBST Anti-Em

    FDA UDI
    BSN MEDICAL, INC.·00035664114633·ANTI EM TH XL-LO W 1 EN FR ES

    StaXx® XDL System

    FDA UDI
    Spine Wave, Inc.·10840642101010·Cartridge Bi-Convex Expandable Implant 37x14x8mm

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089448869·

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213033665·Coupling Treatment Tube for 5F Flexibles (3)

    VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FIBULA COMP LOCK PLATE 10H STE

    FDA Adverse Event
    Injury ·BIOMET TRAUMA·Product code HRS·August 24, 2016

    PRONTO SPOT CHECK PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 9, 2018

    CORONOID PLATE RT STE

    FDA Adverse Event
    Injury ·BIOMET TRAUMA·Product code HRS·June 9, 2016

    HALO PKS CUTTING FORCEPS 5MM/33CM

    FDA Adverse Event
    Malfunction ·GYRUS ACMI·Product code GEI·May 8, 2013

    ASR 300 SPIKED CUP SIZE 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·August 1, 2015

    S3 SHOULDER PLATE 4 HOLE RIGHT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LXT·March 4, 2013

    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025