BEUDAMED
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    STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814558·GENUMEDI SAND SIZE IV

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964074455·Endo Carry-On Procedure Kit

    PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES

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

    DILATING TIP OBTURATOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NEUROGUARD

    FDA Adverse Event
    Injury ·TECHNOMED EUROPE·Product code GXZ·April 21, 2026

    UNKNOWN PATHINDER NXT OR INSTINCT JAVA IMPLANT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code NKB·September 24, 2022

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MRU·December 22, 2015

    ETRIO

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·May 9, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 19, 2014

    ENDURANT BIFURCATED STENT GRAFT

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code MIH·May 4, 2011

    ROD, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019

    PEDICLE SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019

    PEDICLE SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019

    NEUROCOM EQUITEST

    FDA Adverse Event
    Malfunction ·NATUS MEDICAL INCORPORATED·Product code KHX·November 7, 2019

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

    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

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    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

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

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