60 results · 34ms · Sources: EU EUDAMED, US FDA

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Arthrex FiberTak Suture Anchor

FDA 510(k)
FDA Class 2 ·Orthopedic

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114001·CHANG HYDRO-DISSECT CANNULA 27GA

Oph. Cystotomes

FDA UDI
KATENA PRODUCTS, INC.·00841668113707·CYSTOTOME FORMED 23GA

PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Z-TOUCH

FDA 510(k)
FDA Class 2 ·Neurology

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

MANTIS CANNULATED MODULAR TAP 5.5MM

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code HWX·October 14, 2008

ATTAIN STARFIX

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 2, 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