65 results · 26ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform

FDA 510(k)
FDA Class 2 ·Cardiovascular

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113981·HYDRO-DISSECT CANNULA 27GA ANGLED 8MM

Lotion/Gel Warmer

FDA UDI
COMPASS HEALTH BRANDS CORP.·00853904006124·White 3 Bottle Warmer (220V)

OMNIPOD 5 CONTROLLER

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code QFG·August 17, 2022

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MODIFICATION TO EBI SPINELINK SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

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

ATTAIN ABILITY

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

AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code FTL·April 3, 2013

HARMONIC AVE 36 CM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·October 10, 2008

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

ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JIS·March 5, 2012

OMNIPOD 5 POD

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code QFG·July 20, 2022