87 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Z-Span Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Synthes GmbH·10886982144355·3.0MM CANNULATED SCREW SHORT THREAD/24MM
36M - MSHA Miners
FDA UDI
Certified Safety Manufacturing, Inc.·00766588026206·36M - MSHA Miners
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113332·PHACO KNIFE 3.0MM ANGLED (BX/5)
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383513425·"An absorbent paper points is an endodontic pap...
Diamond Orthopedic, LLC
FDA UDI
DIAMOND ORTHOPEDIC, LLC·B551DMD2026240·3.0mm, Cannulated Screw, Short Thd., 24mm
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF2026240·3.0mm Cannulated Screw, Short Thread, 24mm
Deltec
FDA UDI
ICU MEDICAL, INC.·00610586028062·
GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AVITA WRIST TYPE BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Dabir Micropressure
FDA UDI
DABIR SURFACES, INC.·00851343006989·Surface(26" Wide) - Recovery Chair - Micropress...
Dabir Micropressure
FDA UDI
DABIR SURFACES, INC.·00851343006972·Surface(26" Wide) - Recovery Chair - Micropress...
Dabir Micropressure
FDA UDI
DABIR SURFACES, INC.·00851343006965·Surface(26" Wide) - Recovery Chair - Micropress...
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 20, 2025
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R E-CROSS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2023
GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/10 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 31, 2024
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 21, 2026
IVENIX INFUSION SYSTEM
FDA Adverse Event
Malfunction
·FRESENIUS KABI USA LLC·Product code FRN·May 28, 2026
IVENIX INFUSION SYSTEM
FDA Adverse Event
Malfunction
·FRESENIUS KABI USA, LLC·Product code FRN·May 20, 2026
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2024