13 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
KLARITY VACUUM BAG, KLARITY MOLD CUSHION
FDA 510(k)
FDA Class 2
·Radiology
NexxZr™ T / D-100-14-NT-C300-SD
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271113344·
Reef TO
FDA UDI
Seaspine Orthopedics Corporation·10889981204655·Trial, 11mm x 32mm x 12mm, 5 Deg
WaveForm TO
FDA UDI
Seaspine Orthopedics Corporation·10889981288822·Interbody, 11mm x 32mm x 12mm, 5 Deg, 3D
Reef TO
FDA UDI
Seaspine Orthopedics Corporation·10889981190507·Interbody, 11mm x 32mm x 12mm, 5 Deg
DUREX PLAY LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 4, 2013
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·May 29, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·August 21, 2008
COULTER AC*T DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·June 17, 2011
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021