13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MULTIPIEZO PRO, MULTIPIEZO
FDA 510(k)
FDA Class 2
·Dental
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 20, 2008
BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 28, 2017
RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES
FDA 510(k)
FDA Class 2
·Anesthesiology
PLEURX LOCKABLE DRAINAGE LINE SET
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·April 2, 2026
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTM·May 24, 2013
SYNERGY
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 21, 2011
APEX MODULAR HIP STEM
FDA Adverse Event
Injury
·OMNI LIFE SCIENCE, INC·Product code LPH·August 28, 2008
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·September 26, 2025
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·June 2, 2025
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018