14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Halcyon, Ethos Radiotherapy System
FDA 510(k)
FDA Class 2
·Radiology
Capo Slow Flow capsules A 2, 20 x 0.25
FDA UDI
Schütz Dental GmbH·ESDG2321131·Capo Slow Flow is a light-curing, flowable, hig...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112823·BARRON VACUUM PUNCH 9.25MM
Sklar®
FDA UDI
SKLAR CORPORATION·10649111289842·SKLARLITE CRILE FCP CVD 5.5"
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523184514·R Ultracongruent Tibial Insert Trial Sz A 13mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523184279·R CR E-CIMA Vitamin E Ultracongruent Tibial Ins...
Ceragem Automatic Thermal Massager, Model CGM-MB-1901
FDA 510(k)
FDA Class 2
·Physical Medicine
ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
FDA 510(k)
FDA Class 2
·Hematology
MECTALIF ANT - LAG
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·November 4, 2008
UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM (PACKAGED)
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·September 1, 2011
M2A-MAGNUM 52-60MM TPR INS STD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 17, 2013
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026