10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PIONEER LUMBAR PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LEONE SPA
FDA UDI
LEONE SPA·08033707065647·INTRAORAL ELASTICS 2,5 oz 3/16" green
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036027926·
OHMEDA MEDICAL GIRAFFE INCUBATOR
FDA 510(k)
FDA Class 2
·General Hospital
UM-L25
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LANX SPINOUS PROCESS FUSION PLATE
FDA Adverse Event
Injury
·LANX, INC.·Product code KWP·March 17, 2011
FORTIFY ST VR, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 2, 2013
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·September 15, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 16, 2011
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024