BEUDAMED
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    Synvitro Hyadase

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964086021·Endo Carry-On Procedure Kit

    2.0MM/1.5MM DOUBLE DRILL SLEEVE

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·December 4, 2019

    PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VISION ESTHETIC PORCELAIN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·April 24, 2018

    DS2ADV AUTO CPAP

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·May 27, 2024

    DREAMSTATION 2 ADV AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·March 3, 2025

    DS2ADV AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·October 8, 2024

    DS2ADV AUTO CPAP

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·July 30, 2024

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014

    TRIAGE CARDIAC PROFILER KIT

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC·Product code NBC·July 27, 2011

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 1, 2013

    Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

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