BEUDAMED
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    HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241

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

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092117439·NobelBiocare™ Tri-Lobe-compatible WP Esthetic A...

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040128664·Dressing Forceps Eye 4" Serr

    CUSTOM PROCEDURE KIT

    FDA UDI
    MEDIVATORS INC.·40677964006065·The ENDO CARRY-ON Procedure Kit contains all of...

    MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA

    FDA 510(k)
    FDA Class 2 ·Neurology

    CEMENT IT! UNIVERSAL C&B

    FDA 510(k)
    FDA Class 2 ·Dental

    BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE

    FDA Adverse Event
    Malfunction ·SYNTHES SALZBURG·Product code HTD·April 20, 2017

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·March 12, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 24, 2011

    CVC SET: 2-LUMEN 4 FR X 8 CM

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DQY·February 15, 2008

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·April 29, 2018

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·April 29, 2018

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·April 28, 2018

    ZUMA Z2 7F GUIDE CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC·Product code DQY·June 12, 2020

    BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTD·January 24, 2019

    Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·October 3, 2018

    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BrightView, Gamma Camera System, Product Code 882480.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024

    BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016

    882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 22, 2017