26 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SERIM LEUKOCYTE ESTERASE TEST STRIPS
FDA 510(k)
FDA Class 1
·Hematology
PowerPICC
FDA UDI
Bard Access Systems, Inc.·00801741109546·Catheter Placement Kit
GEN4 DIGITAL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828112284·GEN4 DIGITAL
Non-Telescopic PenEvac
FDA UDI
I.C. MEDICAL, INC.·00817688022589·
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 20, 2021
JETLITE 4000
FDA 510(k)
FDA Class 2
·Dental
NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 10, 2024
PRECISE (TM) BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·March 12, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 1, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·February 15, 2008
STERILE 3.5 ULTEM KOH-EFF
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code HEW·January 18, 2022
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012
BrightView, Gamma Camera System, Product Code 882480.
FDA Enforcement
Class II
·Ongoing·Philips North America·January 17, 2024
BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016
882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 22, 2017
BrightView SPECT, Model Number 882480
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 31, 2019
BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018