16 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DigitalDiagnost C50
FDA 510(k)
FDA Class 2
·Radiology
CODMAN
FDA UDI
Cerenovus, Inc.·10886704066903·CODMAN SLIM-LINE Aneurysm Clip Straight Blade L...
Orthopedic manual surgical instrument
FDA UDI
BAUI BIOTECH CO. LTD.·04719883337177·Cage Remover
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856063242·TI ILIAC BONE SCREW ASSY, 8.5MM X 25MM X 15°
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856063259·Ti ILIAC BONE SCREW ASSY, 8.5mm X 25mm X 30°
BETA
FDA UDI
Gc Orthodontics America Inc.·E53573K24017251·BETA-TITA KEYHOLE 17X25 24MM(5 PACK)(SO)
APPLE ECG (ELECTROCARDIOGRAPH) APP
FDA Adverse Event
Injury
·APPLE INC.·Product code QDA·July 5, 2023
BETA
FDA UDI
Gc Orthodontics America Inc.·E53573K26017251·BETA-TITA KEYHOLE 17X25 26MM(5 PACK)(SO)
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A
FDA 510(k)
FDA Class 3
·Cardiovascular
DISETRONIC D-TRON INSULIN INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
POUNCE VENOUS THROMBECTOMY SYSTEM
FDA Adverse Event
Injury
·SURMODICS INC·Product code QEW·May 16, 2024
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·September 18, 2012
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·October 27, 2014
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 4, 2011
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 2, 2013
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