11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AGXO
FDA UDI
Oticon A/S·05707131281210·H160V2, MINIBTE 312 WL 85 CBE AGXO
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962161890·PEDERSON VAGINAL SPECULUM, 5/8"X2 3/4", VIRGIN ...
KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NITRILE POWDER FREE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
CHEMPAQ XBC ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 12, 2025
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 9, 2023
ISERT ASPHERIC INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·HOYA SURGICAL OPTICS, INC.·Product code HQL·June 21, 2011
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·June 6, 2013
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018