10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)
FDA 510(k)
FDA Class 1
·General Hospital
Bernafon
FDA UDI
Bernafon AG·05711584076668·AQ CO9 B 105, 2.4G NFM DPB SABE/MAC ACCUQ
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515026124·Kelley Ret, 2 1/2 x 3", grip handle
Trial Head
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215038380·
CARRIAZO-PENDULAR MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 2, 2008
XENFORM
FDA Adverse Event
Other
·TEI BIOSCIENCES INC·Product code FTM·June 17, 2013
RENAISSANCE 29 P-WASH
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·June 22, 2011
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·December 11, 2013