22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VALIDATE Anemia Calibration Verification/ Linearity Test Kit
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EU-TTG IGA AND EU-TTG IGG
FDA 510(k)
FDA Class 2
·Immunology
MX MONOAXIAL PEDICLE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
ROSA RECON PLATFORM 220V
FDA Adverse Event
Injury
·ZIMMER CAS·Product code OLO·February 1, 2022
ROSA RECON PLATFORM 220V
FDA Adverse Event
Injury
·ZIMMER CAS·Product code OLO·February 4, 2022
ROSA RECON PLATFORM 220V
FDA Adverse Event
Injury
·ZIMMER CAS·Product code OLO·February 1, 2022
ROSA RECON PLATFORM 220V
FDA Adverse Event
Injury
·ZIMMER CAS·Product code OLO·April 4, 2022
ROSA RECON PLATFORM 220V
FDA Adverse Event
Injury
·ZIMMER CAS·Product code OLO·March 9, 2022
ROSA RECON PLATFORM 220V
FDA Adverse Event
Malfunction
·ZIMMER CAS·Product code OLO·March 21, 2022
ALIGN R URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code OTN·May 30, 2013
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 23, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
ROSA RECON PLATFORM 220V
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code OLO·November 8, 2021
ROSA KNEE PLATFORM GB PL G
FDA Adverse Event
Injury
·ZIMMER CAS·Product code OLO·January 13, 2022
ROSA RECON PLATFORM 220V
FDA Adverse Event
Injury
·ZIMMER CAS·Product code OLO·January 10, 2022
ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ROSA RECON PLATFORM 220V
FDA Adverse Event
Injury
·ZIMMER CAS·Product code OLO·April 6, 2022
ROSA RECON PLATFORM 220V
FDA Adverse Event
Injury
·ZIMMER CAS·Product code OLO·January 10, 2022
ROSA RECON PLATFORM 220V
FDA Adverse Event
Injury
·ZIMMER CAS·Product code OLO·May 6, 2022
ROSA RECON PLATFORM 220V
FDA Adverse Event
Malfunction
·ZIMMER CAS·Product code OLO·November 15, 2021