12 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NeuroBlate System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROPELLER HEAD SCREW SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304269255·
OsteoMed
FDA UDI
OSTEOMED LLC·00842528127506·2.0 X 36mm Cannulated Headed Screw, T7
LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DOCTOR SURGERY DIODE LASERS FAMILY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MAGNUM TRISPIKE CUP 52ODX46ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 21, 2013
3002 SECURE II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 22, 2011
TERUMO CENTRIFUGAL SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCUALR SYSTEMS CORP·Product code DTQ·September 22, 2008
DILATOR
FDA Adverse Event
Malfunction
·COOK INC·Product code DRE·August 13, 2021
DILATOR
FDA Adverse Event
Malfunction
·COOK INC·Product code DRE·July 27, 2022
COONS DILATOR
FDA Adverse Event
Malfunction
·COOK INC·Product code DRE·July 28, 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