BEUDAMED
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    SUCTION COAGULATOR

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

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091033003·Baltic Denture System BDLoad ↓ Ln6 PLSEum4DFl C...

    Baby Gorilla/Gorilla Plating System

    FDA UDI
    Paragon 28, Inc.·00889795039651·4.2mm Compression Slot Drill Guide, R3CON

    MONTANE DOLOMITES E-S2.F4 [SZER 69 CM] US

    FDA UDI
    MEDEN INMED SP Z O O·05903684802388·The MONTANE treatment table is a treatment tabl...

    N/A

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024367319·Pearson Attachment, Adult, 64 cm

    TRANSDUCER, S8-3T MICRO TEE

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·August 8, 2014

    APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IMAGECHECKER-CT WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRANSDUCER, S8-3T MICRO TEE

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·March 28, 2014

    TRANSDUCER, S8 3T MICRO TEE

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC·Product code IYO·June 27, 2014

    TRANSDUCER S8-3T MICRO TEE

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·January 24, 2014

    HDI 5000 ULTRASOUND STANDARD SYSTEM

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012

    ARCHITECT I2000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code MMI·April 3, 2013

    SYNCHRON LX 20 PRO CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·March 30, 2011

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FNL·April 24, 2008

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·April 4, 2018

    DIAMONDBACK CORONARY

    FDA Adverse Event
    Injury ·CARDIOVASCULAR SYSTEMS INCORPORATED·Product code MCX·May 1, 2025

    TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).

    FDA Recall
    Terminated ·Radiometer America Inc·Product code LKD·September 27, 2011

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024