26 results · 21ms · Sources: EU EUDAMED, 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