15 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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eUnity
FDA 510(k)
FDA Class 2
·Radiology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111322297·PEAN-NIPPON FCP STR 6 1/4"
QUIDEL MOLECULAR HMPV ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
IGX PLEX CELIAC QUALITATIVE ASSAY
FDA 510(k)
FDA Class 2
·Immunology
UNKNOWN TRIAL POST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 21, 2022
VNGD PS+ TIB BRG 12X71/75MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 27, 2021
BIOMET TIBIAL LOCKING BAR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 27, 2021
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 17, 2013
UROMAX ULTRA BALLOON DILATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code EZN·September 19, 2008
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·June 24, 2011
VAN PS OPEN INTL FEM-RT 67.5
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·September 12, 2023
BIOMET TIBIAL LOCKING BAR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·September 12, 2023
VNGD PS+ TIB BRG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·September 12, 2023
BIOMET CC CRUCIATE TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·September 12, 2023
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
FDA Enforcement
Class II
·Terminated·Cardiovascular Systems Inc·May 31, 2017