12 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KARL STORZ INSULATED SCISSORS AND RECTAL SNARES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Xcaliber Bone Screws
FDA UDI
ORTHOFIX SRL·18054242515869·SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT ...
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665586070·MIS Cannulated Screw M, Ø4.5 x 30mm, Ø5.5mm Rod
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837025090·SOLSTICE Polyaxial Screw Assembly 4.5mm x 30mm
Xcaliber Bone Screws
FDA UDI
ORTHOFIX SRL·18054242518501·SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D...
BRAIN HEART INFUSION W/6.5% SODIUM CHLORIDE
FDA 510(k)
FDA Class 1
·Microbiology
ICAN GT DRAINAGE BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNKNOWN MG-II KNEE BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 9, 2018
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·February 5, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 3, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2014
PKG, MYOMA DRILL 10MM LENGTH 320MM, P/N 0250080134. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014