BEUDAMED
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    GEM-TONE BODY TRAINING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964091025·The ENDO CARRY-ON Procedure Kit contains all of...

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964091056·Endo Carry-On Procedure Kit

    STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CONSENSUS CS2 PLUS ACETABULAR INSERT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BMT GB KNEE STM 12X40

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code OIY·June 1, 2022

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 25, 2012

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 3, 2024

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 9, 2013

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - GUANGZHOU·Product code KDI·September 19, 2014

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL - NEUROMODULATION DIV.·Product code LGW·May 4, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·April 14, 2022

    INTERGRATED APD SET

    FDA Adverse Event
    Malfunction ·VANTIVE US HEALTHCARE LLC·Product code FKX·April 4, 2025

    ORG-9110A

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code DRG·July 1, 2020

    ORG-9110A

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code DRG·July 17, 2020

    Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20-HC G10207 2) JCD14.0-38-20-HC G10293 3) JCD16.0-38-20-HC G10206 4) JCD6.0-38-20-HC G10285 5) JCD8.0-38-20-HC G10289

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·April 24, 2024

    Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20-HC G10207 2) JCD14.0-38-20-HC G10293 3) JCD16.0-38-20-HC G10206 4) JCD6.0-38-20-HC G10285 5) JCD8.0-38-20-HC G10289

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code FGE·March 1, 2024

    REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·March 19, 2014

    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