12 results · 26ms · Sources: EU EUDAMED, US FDA

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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