17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450193518·
CHIN ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
ZEISS INFRARED 800 WITH FLOW 800 OPTION
FDA 510(k)
FDA Class 2
·Radiology
WAVEWRITER ALPHA? PRIME
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 11, 2026
S-ROM*SLEEVE PRX ZTT, 20F-XXL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 2, 2013
SROM*STM ST,36+8L NK,20X15X165
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 2, 2013
ACCU-CHEK ® PERFORMA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 20, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
Other
·INVACARE·Product code ITJ·June 3, 2011
S-ROM M HEAD 36MM +3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 11, 2013
PINNACLE 300 ACET CUP 56MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·April 11, 2013
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 11, 2013
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·August 11, 2020
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
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023