23 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VESOFLOW
FDA 510(k)
FDA Class 2
·Cardiovascular
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306819575·Simpson-St. Mark's Retractor 9", w/Lip
TAPERED SCREW-VENT T IMPLANT
FDA 510(k)
FDA Class 2
·Dental
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE
FDA 510(k)
FDA Class 1
·General Hospital
IMP,TSV,4.7,10,MTX,MG
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·May 22, 2026
IMP,TSV,4.7,11.5,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 12, 2024
IMP,TSV,4.7,10,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 28, 2024
IMP,TSV,4.7,8,MTX,MG
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·April 22, 2026
IMP,TSV,6.0,11.5,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 15, 2025
IMP,TSV,3.7,8,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 12, 2024
IMP,TSV,4.7,10,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 10, 2024
ACTICON NEOSPHINCTER
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code MIP·May 9, 2013
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 2, 2011
IMP,TSV,4.7,11.5,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·November 6, 2024
IMP,TSV,4.7,8,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·November 8, 2024
IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 4, 2023
IMP,TSV,4.7,8,MTX,MG
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·March 17, 2026
IMP,TSV,4.7,11.5,MTX,MG
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·January 20, 2022
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·February 26, 2014