32 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NOxBOXi Nitric Oxide Delivery System
FDA 510(k)
FDA Class 2
·Anesthesiology
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OPAL BAND CEMENT
FDA 510(k)
FDA Class 2
·Dental
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·May 28, 2026
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 22, 2026
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 14, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 22, 2011
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·October 23, 2015
LINER: MPACT FLAT PE HC LINER 36/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·May 27, 2021
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 20, 2025
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXO·May 9, 2025
TRUWAVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 21, 2026
BALL HEADS: MECTACER 01.29.211 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 26, 2023
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·August 21, 2024
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 17, 2025
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 10, 2025
STEM: MASTERLOC CEMENTLESS TI COATED LAT PLUS STEM SIZE 10
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 15, 2021
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·September 5, 2025
MPACT 3D METAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·May 29, 2026