BEUDAMED
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    IVC TWO MEDIUM

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

    Essential Kit

    FDA UDI
    MEDIVATORS INC.·40677964008540·Essential Kit includes Suction Tubing, Pentax 4...

    PowerPICC SOLO

    FDA UDI
    Bard Access Systems, Inc.·00801741188572·Catheter Placement Kit

    LIFEPAK® 12 defibrillator/monitor

    FDA UDI
    PHYSIO-CONTROL, INC.·00721902154119·LP12AABBBBBABBABAABAAAAALP12 MONITOR-DEFIB

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·April 17, 2025

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·April 15, 2025

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·December 19, 2024

    Thermogard™ Vest, S/M

    FDA UDI
    Zoll Circulation, Inc.·00849111076128·Thermogard™ Vest, S/M

    MONOFILAMENT BIOSYN SUTURE

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

    ENHANCED COMPENSATING FILTER

    FDA 510(k)
    FDA Class 2 ·Radiology

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·April 17, 2025

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·April 15, 2025

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 27, 2013

    UNKNOWN ZIMMER MIS TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·February 18, 2011

    COMPACT AIR DRIVE II

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·August 12, 2014

    4F M-I STIFFEN 40CM NT-SS (610366)

    FDA Adverse Event
    Malfunction ·GALT MEDICAL CORP.·Product code DQX·January 10, 2012

    FLOW-I C20 ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code BSZ·June 19, 2025

    FLOW-I C20 ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code BSZ·June 19, 2025

    Brilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311, Serial Numbers: 200005, 200013, and 200047. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011

    Brilliance iCT Computed Tomography X-Ray System, 510 (k) #K060937, Model #728306, Serial Numbers: 100019, 100023, 100087, 100103, and 100170. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011