18 results
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18ms
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Sources: EU EUDAMED, US FDA
VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517405005·CoRoent XL Reserve Implant Tray Base
ZAVATION
FDA UDI
Zavation LLC·00842166118119·Screw Head Positioner
Soundwave Hearing
FDA UDI
Soundwave Hearing, LLC·00850016231239·RIGHT-MEDIUM/991005-SWH; replacement RIC for So...
ZAVATION
FDA UDI
Zavation LLC·00842166189676·Drill, Straight 3.5mm
ZAVATION
FDA UDI
Zavation LLC·00842166189683·Drill, Straight 4.0mm
CD 3700 SL
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·May 23, 2007
CHEMODENT CERAMIC METAL
FDA 510(k)
FDA Class 2
·Dental
ProLift® Expandable System
FDA 510(k)
FDA Class 2
·Orthopedic
GUIDE PIN/SCREW
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613279021·
CELL-DYN 3700 SL ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·February 22, 2019
2520274-2013-01319
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·March 6, 2013
O-F 4000 PLUS
FDA Adverse Event
Injury
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 10, 2011
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·August 8, 2014
UNKNOWN OPSITE FLEXIGRID
FDA Adverse Event
Injury
·SMITH & NEPHEW MEDICAL LTD.·Product code KGX·January 8, 2023
BACTIGRAS
FDA Adverse Event
Injury
·SMITH & NEPHEW MEDICAL LTD.·Product code FRO·January 8, 2023
INFLATOR KIT 18INFKIT BALLOON
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code LRC·August 15, 2014
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024