15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Destino Reach
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100264·KATENA DBL-X ASPIRATING SPECULUM K-WIRE
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100721·SMIRMAUL EYE SPECULUM WIRE
LIGHT CURE RETAINER
FDA 510(k)
FDA Class 2
·Dental
CERAMENT BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
GENERAL PURPOE PROBE COVER
FDA Adverse Event
Malfunction
·ECOLAB MICROTEK·Product code KKX·October 18, 2015
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 7, 2011
POWER HEART G3 AED BATTERY
FDA Adverse Event
Malfunction
·CARDIAC SCIENCE·Product code MKJ·September 5, 2008
UNIVERSA SOFT URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 29, 2019
UNIVERSA SOFT URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK UROLOGICAL INC·Product code FAD·May 13, 2016
UNIVERSA SOFT URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·September 8, 2016
UNIVERSA SOFT URETERAL STENT SET
FDA Adverse Event
Injury
·COOK UROLOGICAL INC·Product code FAD·May 13, 2016
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·July 23, 2019
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023