29 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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S 100 PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
JOBST Bella Strong
FDA UDI
BSN MEDICAL, INC.·00035664012380·BELLA STRONG 20-30 MM HG GAUNTLET SIZE 6 NATURA...
Oticon
FDA UDI
Oticon A/S·05707131158307·VGC, BTE 13 P DBL VIGO CONNECT
Luxe™ 2.5 Semi-custom loupe
FDA UDI
METREX RESEARCH, LLC·00850036373575·Semi-custom loupe with Luxe™ 2.5 plano oculars,...
Tasso+ Convenience Kit
FDA UDI
Tasso Inc.·00860006434588·Tasso+ convenience kit allows self-collection o...
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383502153·Gutta Percha Points is used to root canal filin...
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VSCORE WITH EKG SIGNAL GATING
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 29, 2025
GALILEO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·July 7, 2008
GALILEO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·August 11, 2008
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 4, 2024
ECHO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·November 7, 2008
IOLMASTER 500
FDA Adverse Event
Malfunction
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·October 14, 2015
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·May 3, 2013
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·September 19, 2014
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 11, 2011
UNK LINX MAGNETIC IMPLANT
FDA Adverse Event
Injury
·TORAX MEDICAL, INC.·Product code LEI·August 13, 2025
MicroScan Synergies Plus Dried Overnight Gram Negative MIC/Combo Panels, 20 panels per box. Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria. Catalog numbers B1016-100, B1016-101, B1016-102, B1016-105, B1016-107, B1016-108, B1016-109, B1016-119, B1016-120, B1016-121, B1016-122, B1016-126, B1016-127, B1016-128, B1016-129, B1016-131, B1016-132, B1016-61a, B1016-62a, B1016-64a, B1016-65a, B1016-80, B1016-82, B1017-300, B1017-301, B1017-302, B1017-303, B1017-304, B1017-305, B1017-306, B1017-307, B1017-308, B1017-309, B1017-312, B1017-313, B1017-315, B1017-400, B1017-401, B1017-402, B1017-403, B1017-404, B1017-405, B1017-406, B1017-407, J1016-311c, J1016-312c, J1016-611c, J1016-611j, J1016-612b, J1016-612J, J1016-632J, J1016-623m, J1016-631J, J1016-632J, J1016-65c, J1016-66J, J1025-311, J1025-312, J1025-333, and J1025-611
FDA Recall
Terminated
·Siemens Microscan·Product code LON·July 31, 2008
Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of 6. Item #4043-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline. UPC Red color kit: 845174005464; UPC Lime color kit: 845174005594; UPC Purple color: 845174005600; UPC of master case of 6 845174005471 (2 each color) Item # 4037, Outfitter First Aid Kit, CPR shield with one way valve & barrier filter, brand Lifeline, UPC 845174003453
FDA Enforcement
Class II
·Terminated·Lifeline First Aid LLC·July 13, 2016