13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Traxer Flow Dual Port- Irrigation set for Laser Ureteroscopy - 1 spike
FDA UDI
Promepla·03700512901815·
exsalt PT7 Contact Layer; 16" x 32"
FDA UDI
Exciton Technologies Inc·07540127000499·The exsalt™ PT7 Contact Layer (PT7) is indicate...
Ultracheck
FDA UDI
Statcorp Medical·10841522100925·BP CUFF,MIDMARK, REUSABLE, 1T, LG ADULT, HP, EA
SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
5C-ES CELL CONTROL, MODELS 7547191, 7547192
FDA 510(k)
FDA Class 2
·Hematology
COPPERHEAD CERVICAL INTERBODY CAGE
FDA Adverse Event
Injury
·EMINENT SPINE·Product code ODP·January 8, 2016
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 2, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 15, 2014
XMTR MMT-7703NA MINILINK GST1 17L REPL
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·May 5, 2011
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 13, 2015
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·September 22, 2016
STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
FDA Recall
Terminated
·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011