9 results
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29ms
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Sources: EU EUDAMED, US FDA
Dura-Arch
FDA 510(k)
FDA Class 2
·Dental
Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
L4 OXYGEN CONCENTRATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
SIGNATURE PLUS MICROCOAGULATION SYSTEM
FDA Adverse Event
Malfunction
·INTERNATIONAL TECHNIDYNE CORPORATION·Product code JPA·April 16, 2009
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·December 10, 2008
ADAPTER SLEEVES 12/14 +5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 23, 2011
GREENLIGHT HPS LASER SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS·Product code GEX·July 31, 2013
MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS) Skeletal system: Bone studies. Urinary system: IVP, Cystograms, Percutaneous, Nephrolithotomy, Nephrostomy tube replacement Reproductive system: Hysterosalpingogram, Vena spermatica, Cavernography Respiratory system: Thorax, Bronchoscopy, Pulmonary biopsies Circulatory system: Venography, Arteriography, Thrombolytic Therapy, Em bolizations, Em bolectomy, IVC filter placement, Dilatations, Stent placement. Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·April 3, 2019
MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS) Skeletal system: Bone studies. Urinary system: IVP, Cystograms, Percutaneous, Nephrolithotomy, Nephrostomy tube replacement Reproductive system: Hysterosalpingogram, Vena spermatica, Cavernography Respiratory system: Thorax, Bronchoscopy, Pulmonary biopsies Circulatory system: Venography, Arteriography, Thrombolytic Therapy, Em bolizations, Em bolectomy, IVC filter placement, Dilatations, Stent placement. Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·April 3, 2019