404 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LULLABY LED PHOTTHERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A.
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code LRO·August 15, 2007
CONKLUSION
FDA UDI
SIGNUS Medizintechnik GmbH·04047844006832·The CONKLUSION Pedicle Screw System is a spinal...
PMT® CORPORATION HALO
FDA UDI
PMT CORPORATION·00650551044987·ANTERIOR BED ADAPTER, FOR MAYFIELD RADIOLUCENT
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319703588·Cushing Tissue Forceps 7" (17.5cm), 1x2 teeth
Diversatek Healthcare
FDA UDI
DIVERSATEK HEALTHCARE, INC.·M7831201680·Endoscopy Basic Procedure Kit
SENSEI X ROBOTIC CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
SOLETRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·June 6, 2011
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 20, 2013
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
EUROCHARM INNOVATION CO., LTD·Product code ITJ·September 25, 2014
KING SEPTEMS
FDA Adverse Event
Malfunction
·KING SEPTEMS·Product code LMA·November 1, 2012
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·September 17, 2025
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·September 19, 2025
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code NJR·April 17, 2026
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·May 20, 2026
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·May 14, 2026
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·May 20, 2026
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·May 20, 2026
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·May 20, 2026