30 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Genesys Spine AIS-C Cervical Anchored Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
ORTHOMAP
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252449850·ORTHOMAP¿ VERSATILE HIP 2.0 SALES DEMO
Sleeve, Eccentric
FDA UDI
I.T.S. GmbH·09120047300404·Sleeve, Eccentric, Proximal Humeral Plate
Aura:fit 5.6
FDA UDI
Sonova AG·07613389736274·
Distraction Paddle - 6mm
FDA UDI
CAPTIVA SPINE, INC.·00850065741796·Distraction Paddle - 6mm
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 2, 2022
MEDCOM RT-VIEWER SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
AFINION ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
RD SET YI
FDA Adverse Event
Malfunction
·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021
RD SET DCI
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·February 10, 2023
SOF-FLEX MULTI-LENGTH URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·October 24, 2024
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·July 27, 2011
RINGLOC LINER 28MM 10D/HWALL SZ 24
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·June 20, 2013
PUMP MTT-715NAP PRDGM INS V2.1 PL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·September 26, 2008
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·September 30, 2024
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·October 7, 2024
SOF-FLEX MULTI-LENGTH URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·October 21, 2024
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·April 19, 2021
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·April 19, 2021
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 28, 2022