BEUDAMED
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    THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tasso Mini

    FDA UDI
    Tasso Inc.·00850038691141·

    ScrewPlant®/ ScrewPlus® Implant Analog

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307120421·

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383503143·Gutta Percha Points is used to root canal filin...

    VENUS BASIC SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CKMB UDR ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·February 4, 2022

    SYNGO SUITE FOR ONCOLOGY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 19, 2014

    OCTRODE LEAD, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2011

    BONE SCREW SELF-TAPPING 6.5 MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·August 25, 2025

    G7 OSSEOTI MULTIHOLE 54MM F

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·August 26, 2025

    36MM I.D. SIZE F HIGH WALL LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·January 27, 2026

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 26, 2026

    7F ZUMA 2 SR3.5 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27SR35SH

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

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

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

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