11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MiniCollect K2E K2EDTA Tubes
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515026575·Harrington Ret, large
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
RADIOLOGICAL IMAGE PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·October 17, 2014
BLACKMAX-NEURO LOW PRESSURE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HSZ·June 21, 2013
GOBED+
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 22, 2011
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Injury
·COOK INC·Product code KRA·April 27, 2022
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·April 11, 2022
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·August 19, 2022
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