15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REVIVATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450755747·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0140030·Cap Starter, T30, Split Tip, Quarter Square
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07310K0140030·Counter Torque, Tower Tab
TRANSDUCER, S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·August 8, 2014
GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT
FDA 510(k)
FDA Class 2
·Ophthalmic
PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30
FDA 510(k)
FDA Class 2
·Orthopedic
TRANSDUCER, S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·March 28, 2014
TRANSDUCER, S8 3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC·Product code IYO·June 27, 2014
TRANSDUCER S8-3T MICRO TEE
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·January 24, 2014
HDI 5000 ULTRASOUND STANDARD SYSTEM
FDA Adverse Event
Malfunction
·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012
SD/PD MEDIUM CURVED
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·May 6, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·May 13, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 5, 2008
LIFEPAK CR Plus defibrillator
FDA Recall
Terminated
·Medtronic Physio Control Corp·Product code MKJ·May 23, 2003