2,876 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR)
FDA 510(k)
FDA Class 1
·General Hospital
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964074370·Endo Carry-On Procedure Kit
Integra®
FDA UDI
INTEGRA PAIN MANAGEMENT·10381780260349·SINGLE SHOT EPIDURAL TRAY
300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC
FDA 510(k)
FDA Class 2
·Radiology
STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 9, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·September 19, 2014
ACT III SENSOR
FDA Adverse Event
Malfunction
·LIFEWATCH SERVICES, INC.·Product code DSI·May 4, 2011
TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·September 5, 2012
EVOKE CAP12 TRIAL PERCUTANEOUS LEAD KIT - 60CM (US)
FDA Adverse Event
Injury
·SALUDA MEDICAL PTY LTD·Product code LGW·October 10, 2025
IMP,TSV,MCOL MG,4.7MM,10M
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 13, 2026
IMP,TSV,MCOL MG,6.0MM,11MM,MTX
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 18, 2026
EVOKE CAP12 TRIAL PERCUTANEOUS LEAD KIT - 60CM (US)
FDA Adverse Event
Injury
·SALUDA MEDICAL PTY LTD·Product code LGW·October 10, 2025
IMP,TSV,MCOL MG,4.7MM,11.5MML
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·March 30, 2026
IMP,TSV,4.7,8,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·August 15, 2022
IMP,TSV,6.0,13,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 26, 2020
IMP,TSV,MCOL MG,4.7MM,8MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·August 4, 2022
IMP,TSV,4.7,11.5,MTX,MG
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 18, 2026
IMP,TSV,MCOL MG,4.7MM,10M
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 22, 2026
IMP,TSV,4.7,10,MTX,MG
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·April 22, 2026