26 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Optima XR646
FDA 510(k)
FDA Class 2
·Radiology
VACCESS LT LONG-TERM HEMODIALYSIS CATHETER PLUS
FDA UDI
Bard Access Systems, Inc.·00801741010989·VACCESS PLUS, ST, 16 FR. 27cm
SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
INSTINCT JAVA SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 11X300MM X 1
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 19, 2012
ZEPHYR XL SR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DXY·January 13, 2014
IMPAX CV DICOMSTORE WITH MEDIA PURGE DAEMON (MPD)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 3, 2013
GALILEO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·June 28, 2011
Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .
FDA Enforcement
Class II
·Terminated·Laserex Systems Inc.·April 13, 2016
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 31, 2019
PKG, GRASPER FORCEPS, TISSUE, P/N 0250080284. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 31, 2019
5.5 EXP VERSE DI SET SCR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017
5.5 EXP VERSE UNITIZED SET SCR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017
5.5 EXP VERSE CAN SCR 7.0X45
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017
5.5 EXP VERSE CAN SCR 7.0X45
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NKB·December 21, 2017