21 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
s-Clean Tapered II RBM Implant System
FDA 510(k)
FDA Class 2
·Dental
Tungsten Carbide Burr
FDA UDI
ELLIQUENCE, LLC·00846338003920·
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193023964·B-P MODULAR EXTENSION W/ULTRACOAT - 13 MM X 50 MM
VIDAS® MEASLES IGG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LJB·February 12, 2016
GE DATEX-OHMEDA AISYS
FDA 510(k)
FDA Class 2
·Anesthesiology
LUMANOSITY CELEBRITY, MODEL 204
FDA 510(k)
FDA Class 2
·Physical Medicine
FLEXITRUNK INFANT NASAL TUBING
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZO·July 26, 2016
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·March 8, 2018
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 10, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·September 19, 2014
HUDSON NEONATAL VENTILATOR CIRCUIT W/18 IN R
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZO·June 2, 2011
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 12, 2020
OHICHO3
FDA Adverse Event
Injury
·Product code LIT·July 19, 2019
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 14, 2020
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·September 30, 2020
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·May 28, 2020
OHICHO3
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·September 26, 2018
OHICHO3
FDA Adverse Event
Injury
·Product code LIT·September 17, 2019
Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016
SURESTEP
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code CGA·May 22, 1998