BEUDAMED
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    AMBIT CONTINUOUS AMBULATORY INFUSION PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033325·Baltic Denture System BDLoad BDLoad ↓ Mn6 PLSEu...

    ECG Module Kit(2127/AHA)

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904089539·

    POINT 4 FLOWABLE 2

    FDA 510(k)
    FDA Class 2 ·Dental

    KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM

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

    D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·February 27, 2014

    D903 DIDECO AVANT 2 VAVD PHISIO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·February 19, 2014

    IT PADOVA

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·August 8, 2013

    D903 DIDECO AVANT VAVD PHISIO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·August 16, 2013

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code MUZ·April 3, 2013

    MX-PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·March 22, 2011

    VITROS IMMUNODIAGNOSTICS PRODUCT TROPI ES REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·August 25, 2014

    C20441 IL HAIFA

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DWF·March 28, 2012

    PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBH·October 20, 2025

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    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