BEUDAMED
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    THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAXCUT CARBIDE BUR (10/pk) FG 700

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D77811114171·MAXCUT CARBIDE BUR (10/pk) Shape: Cross Cut Tap...

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089448692·

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613058876·Doyen Rasps, Overall Length 6-3/4" (172mm)

    ULTRASOUND SCANNER, TYPE 2102

    FDA 510(k)
    FDA Class 2 ·Radiology

    BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·March 7, 2022

    ASR ACETABULAR IMPLANT 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 14, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

    SUMMIT POR TAPER SZ4 STD OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code MRA·May 13, 2011

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·December 8, 2017

    OmniDiagnost Eleva System codes 708028 708027

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    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

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    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 L131, ESSENTIO DR EL MRI Pacemaker

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