BEUDAMED
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    ORTHOPEDIC ALLIANCE SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033826·Baltic Denture System BDLoad BDLoad Sw7 PLSEbm...

    FOCUS DAILIES PROGRESSIVES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Radiology

    MICROSTAAR INJECTOR

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL·Product code KYB·February 21, 2007

    MICROSTAAR INJECTOR

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code KYB·February 21, 2007

    R90 SPACERS

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code MQP·October 9, 2009

    R90 SPACERS

    FDA Adverse Event
    Other ·WARSAW ORTHOPEDIC INC·Product code MAX·November 6, 2009

    R90 SPACERS

    FDA Adverse Event
    Injury ·SOFAMOR DANEK DEGGENDORF GMBH·Product code MAX·December 21, 2009

    OPEN SPINE CLAMP, TITANIUM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 3, 2013

    4 MOTOR ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 23, 2011

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES,INC·Product code MIH·April 24, 2008

    AXIOM ARISTOS VX PLUS

    FDA Adverse Event
    Injury ·SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD·Product code MQB·April 7, 2021

    R90 SPACER

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code NKB·August 5, 2011

    Brilliance 64 Computed Tomography X-Ray System, 510(k) #K033326, Model Number: 728231, Serial Numbers: 9745, 90169, and 95414. The recalled device systems are equipped with Version 3.5 Beta 1 software.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 22, 2011

    Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, and 300005. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device 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·August 29, 2011

    Brilliance 64 CT (Computed Tomography) System, 510 (k) #K033326, Model #728231, Serial Numbers: 4003, 9875, and 90135. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device 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·August 29, 2011

    Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021. Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device 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·November 11, 2011

    Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device 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·September 6, 2011

    Ingenuity CT computed Tomography System, Model #728326, 510(k) #K 033326, Serial Numbers: 300010 and 300018. The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device 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·September 6, 2011