21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONDUIT TCP GRANULES
FDA 510(k)
FDA Class 2
·Orthopedic
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033557167·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033557211·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033557204·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033557174·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033557198·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0140030·Cap Starter, T30, Split Tip, Quarter Square
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033557143·
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01405N0·Cervical Rasp, 15 x 12, 5mm, 0 Degree, No Taper
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07310K0140030·Counter Torque, Tower Tab
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033557181·
M2376A DEVICELINK SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
HUMI-FLOW, MODEL 6-850-00/ 01/02
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NA
FDA UDI
Zimmer, Inc.·00889024458956·
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
IDENTITY XL DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011
L-70 HOTLINE 2 FLUID WARMING SET WITHOUT INJECTION PORT
FDA Adverse Event
Death
·SMITHS MEDICAL ASD, INC.·Product code FPA·March 12, 2008
OXFORD UNI FEMORAL MD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code NRA·June 13, 2014
Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212
FDA Enforcement
Class II
·Terminated·Cadence Inc.·August 19, 2015
ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·June 4, 2014