10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Propeller Sensor for Symbicort
FDA 510(k)
FDA Class 2
·Anesthesiology
ANKLE ARTHRODESIS NAIL, LEFT 10X150MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INTERLOCK?-35
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRD·October 22, 2014
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
FDA Adverse Event
ANGIOSCORE, INC.·Product code NWX·June 21, 2013
T-FLEX ASPHERIC
FDA Adverse Event
Malfunction
·RAYNER INTRAOCULAR LENSES LTD.·Product code HQL·July 22, 2011
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
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)
FDA Enforcement
Class II
·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023