BEUDAMED
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    INFRARED EAR THEROMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776306410·KELLY-GRAY UTERINE CURETTE SERRATED CUT EDGE SI...

    ONE Super Studs

    FDA UDI
    GLOBAL PROTECTION CORP.·00726893112155·3 Lubricated Male Latex Condoms

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071117030C0·Cone Ring Curette #3 STR 17" 9" handle

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071117030S0·#3 Cone Ring Curette 17" 7" handle

    K2M Fenestrated Tap System

    FDA UDI
    VB Spine LLC·10888857530065·Tap, Fenestrated Size Ø5.5

    Surgical Direct

    FDA UDI
    Surgical Direct, Inc.·B382SD220881117030·8 3/4" Malis Bayonet Bipolar Forceps with Irrig...

    MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES

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

    PRONTO SPOT CHECK PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 9, 2018

    BD INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015

    12MM/130 DEG TI CANN TFNA 170MM - STERILE

    FDA Adverse Event
    Injury ·WRIGHTS LANE: SYNTHES USA PRODUCTS LLC·Product code HSB·January 17, 2018

    BARD TENSION FREE BLADDER SLING

    FDA Adverse Event
    Injury ·BARD MEDICAL DIVISION·Product code PAG·May 8, 2013

    STRATA II VALVE, REGULAR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·May 25, 2011

    DASH 4000

    FDA Adverse Event
    Other ·GE HEALTHCARE·Product code MHX·August 13, 2008

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/1.5 cm/90 cm, Reference Catalog Number 38990-5015

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.

    FDA Enforcement
    Class II ·Terminated·Monteris Medical Corp·November 26, 2014

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018