13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABL80 FLEX CO-OX with AQURE connectivity
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304674592·
TRANS1 FACET SCREWS
FDA 510(k)
FDA Unclassified
·Unknown
ELECSYS CEA CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
QUADRA-H CEMENTLESS, HA COATED STEM 4 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·January 27, 2017
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 8, 2014
7" SMALLBORE PRESSURE INFUSION EXT. SET
FDA Adverse Event
Other
·ICU MEDICAL, INC.·Product code FPA·May 20, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 6, 2011
BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 10, 2023
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
FDA Recall
Terminated
·Theralase Inc.·Product code NHN·September 26, 2019
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
FDA Recall
Terminated
·Theralase Inc.·Product code NHN·September 26, 2019
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023