18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACR Screw System
FDA 510(k)
FDA Class 2
·Dental
ORTHOCORD HEALIX TI
FDA UDI
Medos International Sàrl·10886705007912·HEALIX Ti Anchor w/ORTHOCORD Titanium Anchor (1...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970478·
Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning
FDA 510(k)
FDA Class 2
·Neurology
G-FERT, MODEL 10033
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NA
FDA UDI
Exactech, Inc.·10885862282880·TRIAL, MONOBLOC REVISION STEM, 22x245mm
N/A
FDA UDI
Exactech, Inc.·10885862659996·Trial, Monobloc Revision Stem
INSYTE AUTOGUARD
FDA Adverse Event
BD INFUSION THERAPY SYSTEMS, INC.·Product code FOZ·October 28, 2008
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·August 24, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 12, 2013
BD¿ PRN ADAPTER
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·June 20, 2023
BD¿ PRN ADAPTER
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·June 20, 2023
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·August 20, 2024
COPAN WASP/COLIBRI
FDA Adverse Event
Other
·COPAN WASP·Product code QQV·July 25, 2024
BD PRN ADAPTOR
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FPA·June 16, 2023
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·November 18, 2024
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025