11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776300142·Cystoscopy Sheath Obturator System
Misc
FDA UDI
ORMCO CORPORATION·00889989054972·LINGUAL ELASTILUG FLAT EACH
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K1430220·Rod Cutter, Table Top
STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SORIN FLEXTHERM
FDA 510(k)
FDA Class 2
·Cardiovascular
FOLEY CATHETER, 3W STD SLC CH16
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code KOD·May 29, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI PLANT - ST. PAUL·Product code LWS·October 3, 2014
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·June 25, 2011
Exergen Temporal Scanner
FDA UDI
EXERGEN CORPORATION·00834098002109·TAT2000C Temporal Scanner
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013