11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ellusa Reusable Neutral Plates
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEALIX ADVANCE
FDA UDI
Medos International Sàrl·10886705030606·HEALIX ADVANCE SP PEEK ANCHOR 5.5mm
VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCREWLINE
FDA 510(k)
FDA Class 2
·Dental
5.5MM HEALX ADV SP PEEK ANCHOR
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL·Product code MAI·February 18, 2020
HEALIX ADVANCE SP ANCHOR (MITEK
FDA Adverse Event
Injury
·DEPUY MITEK, INC.·Product code MAI·August 26, 2020
SYNCHROMED
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·November 5, 2008
PAD CONNECTOR CABLE
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 14, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·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 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