60 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
FDA 510(k)
FDA Class 2
·Anesthesiology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114001·CHANG HYDRO-DISSECT CANNULA 27GA
Oph. Cystotomes
FDA UDI
KATENA PRODUCTS, INC.·00841668113707·CYSTOTOME FORMED 23GA
AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
FDA 510(k)
FDA Class 2
·Clinical Chemistry
JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR
FDA 510(k)
FDA Class 2
·General Hospital
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
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·July 25, 2022
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·February 13, 2023
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·February 13, 2023
OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·October 4, 2022
OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·October 4, 2022
CURLIN
FDA Adverse Event
Malfunction
·CURLIN MEDICAL, INC.·Product code FPA·October 9, 2008
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011
MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·July 3, 2013
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·February 13, 2023
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·June 1, 2023
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·October 5, 2022
OMNIPOD 5 CONTROLLER
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·October 31, 2022
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·July 20, 2022
OMNIPOD 5 CONTROLLER
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·September 24, 2022