BEUDAMED
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    COOLGARD 3000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Mini-Mono®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70603081·Mini-Mono-Brackets Roth 'N' .018" 9° 100 Bracke...

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306813535·Singley Cervical Forceps, 41cm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024038·Paddle Shaver, 8mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103080·Shaver, Closed, 8mm

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K0600080·Try insert, InTess C Level 1

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0600080·Tray Insert, Lumbar Rods

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0600080·Tray Insert, Level I

    Kalitec Disc Prep

    FDA UDI
    Kalitec Direct LLC·B07319K0600080·Tray Insert, Disc Prep 1

    VANGUARD COMPLETE KNEE CRUCIATE RETAINING POROUS & HA FEMUR LEFT 75MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MBH·December 16, 2016

    REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE

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

    WALLSTENT BILIARY ENDOPROSTHESIS

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

    CONFIDENCE KIT, NO NEEDLES

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES SPINE·Product code NDN·April 1, 2014

    NICOLET ONE MONITOR ON ERGO CART

    FDA Adverse Event
    Injury ·NATUS NEUROLOGY INCORPORATED·Product code OLV·April 11, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 15, 2011

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code LWR·June 12, 2008

    ALARIS SYSTEM PC UNIT

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 6, 2020

    Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.

    FDA Enforcement
    Class II ·Terminated·Pharmaceutical Innovations, Inc.·August 26, 2020

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022