10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
McKesson
FDA UDI
MCKESSON MEDICAL-SURGICAL INC.·10612479267838·ADMIN KIT: UNIVERSAL-300 (PED)
BLOOD PRESSURE MONITOR, MODEL KP-7000
FDA 510(k)
FDA Class 2
·Cardiovascular
LIAISON 25 TOTAL-D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GE OEC 9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008
MESH - VENTRALEX
FDA Adverse Event
Injury
·DAVOL INC·Product code FTL·August 25, 2011
ACCU-CHEK ® SMARTVIEW TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 18, 2013
LGN PS HIGH FLEX XLPE SZ 5-6 15MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·February 18, 2019
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025