11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HORIZON 55 BI-CON TORIC
FDA 510(k)
FDA Class 2
·Ophthalmic
Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Nerveblox
FDA 510(k)
FDA Class 2
·Anesthesiology
CAPTURED HIP SCREW 135 DEGREE 4 HOLE PLATE
FDA Adverse Event
Malfunction
·BIOMET TRAUMA·Product code KTT·May 3, 2017
CAPTURED HIP SCREW LAG SCREW
FDA Adverse Event
Malfunction
·BIOMET TRAUMA·Product code KTT·May 3, 2017
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·February 8, 2013
EASYTRAK 3
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·January 6, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 22, 2014
1820334-2020-01805
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·October 5, 2020
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024