13 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777464·LUMBAMED PLUS FLEX PAD WM SILVER IV
ARGENCO HP 77 (5 dwt)
FDA UDI
ARGEN CORPORATION, THE·D818120244·Gold based noble metal
JOBST soSoft
FDA UDI
BSN MEDICAL, INC.·00035664007508·SOSOFT 8-15 MM HG KNEE HIGH BROCADE MEDIUM WHIT...
METRO SOFT
FDA 510(k)
FDA Class 2
·Ophthalmic
SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP)
FDA 510(k)
FDA Class 2
·Orthopedic
TROJAN PLEASURE PACK LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 2, 2023
SYRINGE 10ML SALINE FILL CHINA SP
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·December 15, 2020
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 20, 2013
AGILIS INTRODUCER, UNKNOWN
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, AF DIVISIION·Product code DYB·June 7, 2011
AFFINITY 4
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code HDD·August 14, 2008
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