12 results
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26ms
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Sources: EU EUDAMED, US FDA
CYTOGUIDE
FDA 510(k)
FDA Class 2
·Radiology
KEYPORT
FDA UDI
Richard Wolf GmbH·04055207011355·TROCAR SLEEVE SINGLE PORT 31MM plastic sleeve ...
Surgical Direct
FDA UDI
Surgical Direct, Inc.·B382SD438850200·Complete Omni Style Standard Retractor Set, Wit...
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011885020000·dentaform® Band, Tooth 36, Size 20
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011885020180·dentaform® Band, Tooth 36, Size 20/Roth 18
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011885020220·dentaform® Band, Tooth 36, Size 20/Roth 22
SYSTE MATE IRON, HEM NO. 67224
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MEDICAL DYNAMICS CCD SOLID STATE VIDEO CAMERA 5930
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CARPENTIER-EDWARDS PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·June 19, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·October 20, 2010
UNKNOWN LEFT NECK
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·December 12, 2012
Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag Spike/CL-17; 8 IN (20cm) APPX 1.0ml, EXT SET, MicroClave Clear, ChemoLock PORT, YCONN/CL3950; 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Purple Cap, Hanger/CL3951; 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock Port, Clamp, Graduated Adapter/CL3967; 6 IN(15cm)APPX 0.82ml,EXT SET,MicroClave Clear,ChemoLock PORT,YCONN, ROTATING LUER/CL4118; ChemoLock Kit w/ 5" (13 cm) Bag Spike Adapter w/ChemoLock w/Red Cap, Vented Cap, ChemoLock Port Bag Spike/CL4158; ChemosafeLock Bag Spike/KL-BS001U3; ChemosafeLock Vial Adapter/KL-VA201U3; ChemosafeLock Vial Adapter/KL-VA202U3; ChemosafeLock Vial Adapter/KL-VA321U3; ChemosafeLock Vial Adapter/KL-VA322U3; ChemoLock Vented Vial Spike/011-CL-51; Transfer Set, PUR Yellow w/ChemoLock Port, Spiros/011-CL4155; Puerto ChemoLock/034-CL2100; ChemoLock, Punzon Univ. Vial c/ Filtro, fijacion/034-CL-70; ChemoLock, Punzon Vial Tritan c/ Filtro, 13mm/034-CL-72
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·September 14, 2022