20 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ZQUIET PRO-PLUS
FDA 510(k)
FDA Class 2
·Dental
XTRACT SYRINGE KEY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012
AGC DA2000 KN TIB BRG 71/75X8
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·April 9, 2026
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012
OBTAPE TRANSOBTURATOR SLING
FDA Adverse Event
Injury
·MENTOR WORLDWIDE LLC·Product code OTN·May 8, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·June 13, 2011
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 18, 2012
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
VANGUARD ROCC POR FEM S55 R
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code MBH·January 22, 2026
VANGUARD ROCC POR FEM S57.5 L
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code MBH·January 22, 2026
VANGUARD ROCC POR FEM S57.5 L
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBH·May 13, 2025
TINBN VANGUARD INT PS ANAT FM R 75MM
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code MBH·June 4, 2025
VANGUARD ROCC POR FEM S55 R
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBH·June 4, 2025
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024