40 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BioWave BioWraps
FDA 510(k)
FDA Class 2
·Neurology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113929·GIANNETTI HYDRODISS CANNULA 26GA
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112939·CORNEAL TREPHINE BLADE8.0MM
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113837·VISCO CANNULA 23GA ANGLE 8MM
ROCHE DIAGNOSTICS CK-MB
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RANDOX APOLIPOPROTEIN CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·December 17, 2002
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 30, 2025
SYNCHRON LX I 725 CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·October 17, 2008
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
BREG POST OP SHOE
FDA Adverse Event
Malfunction
·BREG, INC.·Product code IQI·July 2, 2013
Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300
FDA Enforcement
Class II
·Terminated·Anodyne Surgical·June 23, 2021
Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300
FDA Recall
Terminated
·Anodyne Surgical·Product code HMX·April 21, 2021
CHECK-IT
FDA Adverse Event
Malfunction
·PFIZER, INC.·Product code QJR·May 23, 2023
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 1, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 1, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·August 25, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 8, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 8, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 8, 2022