14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VENUE 50
FDA 510(k)
FDA Class 2
·Radiology
AGXO
FDA UDI
Oticon A/S·05707131262202·H110, RITE 312 WL STG AGXO
ELATION® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807133431611·ELATION® MB Base Rx 018/LL3 -11T 7A HK
LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ
FDA 510(k)
FDA Class 2
·Radiology
COREN TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CAD II
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·October 1, 2014
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·Product code NBW·May 29, 2013
PULSE GEN MODEL 101
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·June 15, 2011
THERMAGE CPT SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code GEI·November 12, 2020
THERMAGE CPT SYSTEM TIP
FDA Adverse Event
Injury
·SOLTA MEDICAL INC·Product code GEI·November 30, 2022
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
Philips Respironics DreamWear Full Face Mask
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·October 12, 2022
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
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015