18 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ProMin Dental Desensitizing Gel
FDA 510(k)
FDA Class 2
·Dental
Unity Total Knee System
FDA UDI
CORIN LTD·05056139233739·Unity ASC IM Rod
MaXcess
FDA UDI
Nuvasive, Inc.·00887517193650·MaXcess Access Blade, 60mm Left
MONOBLOC REAMER 6.0mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665000740·
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780424932·Integra® Miltex® Jackson Tracheal Bistoury 7", ...
NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
CLEARGUARD HD END CAP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Regatta Lateral System
FDA UDI
Seaspine Orthopedics Corporation·10889981158880·Lateral Implant, 23mm x 10mm x 60mm, 10 Deg
Regatta Lateral System
FDA UDI
Seaspine Orthopedics Corporation·10889981162177·Lateral Implant, 23mm x 10mm x 60mm, 15 Deg
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
Vu aPod™ - L
FDA UDI
Seaspine Orthopedics Corporation·10889981046675·LATERAL IMPLANT, WIDE, LORDOTIC, 10mm X 23mm X ...
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP 2M8063,
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
PLUM XLD 110V L.A.
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 12, 2013
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025