12 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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