10 results
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26ms
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Sources: EU EUDAMED, US FDA
GODAT UTERINE MANIPULATOR INJECTOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SIC® Dental Implant Systems
FDA UDI
SIC invent AG·ESIC9350231·SIC Gingiva Shaper Ø 3.3 mm, cylindrical, GH 2....
SIC® Dental Implant Systems
FDA UDI
SIC invent AG·04260516870085·SIC Gingiva Shaper Ø 3.3 mm, cylindrical, GH 2....
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690128489·Congruent Tibial Insert, Size 2 x 13mm
AMSET LOCKING PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE
FDA 510(k)
FDA Class 2
·Ophthalmic
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·December 21, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HLTHCARE CORP·Product code FRN·February 4, 2014
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 21, 2012
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022