42 results
·
27ms
·
Sources: EU EUDAMED, US FDA
NEO NEST
FDA 510(k)
FDA Class 1
·Physical Medicine
HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COROENT INTERLOCK SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 4, 2024
COULTER® LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 14, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014
QUANTUM TTC ESOPHAGEAL BALLOON DILATOR
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNQ·May 26, 2011
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO
FDA Adverse Event
Malfunction
·MAKO SURGICAL·Product code OLO·April 25, 2014
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 22, 2024
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO
FDA Adverse Event
Malfunction
·MAKO SURGICAL·Product code NPJ·April 25, 2014
LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 13, 2023
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 17, 2024
LOGIC FEMORAL PS CEM LEFT SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 5, 2025
LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 30, 2022
LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 5, 2024
LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 11, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 22, 2024
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 26, 2023
OPTETRAK LOGIC
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 7, 2023
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 11, 2023