15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RSCRIBE ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
Mini Unicycle™
FDA UDI
Ortho Organizers, Inc.·00190707056735·Mini Unicycle™ .120” Ligature Ties - Gray
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319720387·Bishop-Harmon Micro Tissue Forceps 3-3/8" (8.6c...
AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX
FDA 510(k)
FDA Class 2
·Orthopedic
ONLINE POWDER FREE, LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ASR ACETABULAR IMPLANT 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 20, 2013
M2A MAGNUM MODULAR HEAD 44MM HEAD DIAMETER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 11, 2011
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·August 15, 2008
KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·August 8, 2012
DIVA
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 7, 2020
DIVA
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 7, 2020
SENRI
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code DQY·December 25, 2016
VERSE POLY DRIVER SHAFT NAV
FDA Adverse Event
Malfunction
·DEPUY SPINE INC·Product code OLO·April 29, 2022
MEGA 7.5FR. 40CC
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 10, 2020
METACROSS RX PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·October 15, 2019