9 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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645OB SECTOR/LINEAR ULTRASOUND SCANNER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809643497·OPAQUE MATERNITY 15-20 MM HG WAIST HIGH ZIG ZAG...
Toricolors (hioxifilcon D) Soft Contact Lenses
FDA 510(k)
FDA Class 2
·Ophthalmic
SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101
FDA 510(k)
FDA Class 2
·Cardiovascular
POLYFORM SYNTHETIC MESH
FDA Adverse Event
Injury
·PROXY BIOMEDICAL LTD.·Product code FTL·May 2, 2014
MEDEX INJECTION ADAPTER WITH MALE LUER LOCK
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code FPA·October 4, 2010
FENESTRATED BIPOLAR FORCEPS
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·December 7, 2012
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012