13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BRACHYTHERAPY STRAND DEVICE
FDA 510(k)
FDA Class 2
·Radiology
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201502679·FIXATION SCREW 35 MM, TITANIUM
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291101475·SS Suture, 6 per sleeve
ENDOCARE PERCUTANEOUS ACCESS SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
81 CM (32") APPX 5.1 ML, 20 DROP BLOOD SET W/200 MICRON FILTER, ROTATING LUER, B
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FJK·September 23, 2019
COMPLETE
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LPN·April 17, 2020
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 15, 2014
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 15, 2011
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·September 6, 2012
6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018
6.5MM TI RECON SCREW WITH T25 STARDRIVE 105MM
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018