12 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER
FDA 510(k)
FDA Class 2
·Anesthesiology
AngioSystems Tray
FDA UDI
ANGIOSYSTEMS, INCORPORATED·00816611026458·
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981124151·5mm, 2-Hole Anterior Plate
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515224124·Tessier Retromaxillary Level, left, 15cm, 6"
MINI OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K85055231·MINI OVATION® Base Rx 022 UL/5-5 CS HK
MINI OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K85055241·MINI OVATION® Base Rx 022 UL/5-5 CS-BC MHK
Cellfina System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEPOTONE
FDA 510(k)
FDA Class 2
·General Hospital
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·SMALL BONE INNOVATIONS, INC.·Product code NTG·May 20, 2014
LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDL·October 1, 2010
6600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 27, 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