38 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Insight Enhanced DRF Digital Imaging System
FDA 510(k)
FDA Class 2
·Radiology
CUSHING TYING FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060814·CUSHING TYING FORCEPS TUNGSTEN CARBIDE INSERT P...
TMC Nanoplasty System
FDA UDI
Treace Medical Concepts, Inc.·00810111224758·Drill Guide
APNOESCREEN PRO, ALPHA SCREEN PRO
FDA 510(k)
FDA Class 2
·Anesthesiology
BIOCELLECT -PERIO
FDA 510(k)
FDA Class 2
·Dental
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 31, 2025
MPACT EXTENSION
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·April 2, 2026
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 18, 2025
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2024
INDURA
FDA Adverse Event
Injury
·NEUROLOGICAL DIVISION, MEDTRONIC INC.·Product code LKK·July 24, 2007
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 28, 2025
INDURA
FDA Adverse Event
Injury
·NEUROLOGICAL DIV, MEDTRONIC, INC.·Product code LKK·July 24, 2007
AMISTEM-P
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·August 26, 2025
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 19, 2025
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 21, 2024
AMISTEM-P COLLARED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 13, 2025
T:SLIM X2 INSULIN PUMP
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·October 3, 2017
INDURA
FDA Adverse Event
Injury
·NEUROLOGICAL DIVISION, MEDTRONIC INC.·Product code LKK·July 24, 2007
LINER: MPACT FLAT PE HC LINER Ø28/B
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·August 3, 2022