BEUDAMED
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    One Step Pregnancy Test

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777433·LUMBAMED PLUS FLEX PAD WM SILVER I

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319722060·Maltz Nasal Rasp 7" (17.5cm), forward (upward) ...

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551068310·STEALTH sEEG KIT: 2103-95 (QTY 2), 2103-52, 210...

    PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,,

    FDA 510(k)
    FDA Class 2 ·Neurology

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·August 8, 2014

    SHILEY PEDIATRIC CUFFED LONG

    FDA Adverse Event
    Injury ·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code JOH·August 8, 2011

    ENDOTAK RELIANCE

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

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number LC4203 (Reorder No. 21-0341-01) 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 2 needleless Injection sites.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·August 10, 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 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