24 results · 31ms · Sources: EU EUDAMED, US FDA

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Insignis Subcutaneous Needle Sets

FDA 510(k)
FDA Class 2 ·General Hospital

APS INPUT OUTPUT MODULE

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING INC·Product code JQP·July 4, 2012

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112649·BARRON CORNEAL PUNCH 8.25MM

36M - Navajo Tribal Utility Authority

FDA UDI
Certified Safety Manufacturing, Inc.·00766588012797·36M - Navajo Tribal Utility Authority

ML EYE SPEAR, MODEL ML 27 ES

FDA 510(k)
FDA Class 2 ·Ophthalmic

INCU I

FDA 510(k)
FDA Class 2 ·General Hospital

IMED

FDA Adverse Event
Injury ·IMED CORPORATION·Product code FRN·June 16, 2006

ENDURANT STENT GRAFT

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·April 11, 2022

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 27, 2014

UNKNOWN PAINPUMP PRODUCT

FDA Adverse Event
Injury ·STRYKER INSTRUMENTS KALAMAZOO·Product code FRN·July 26, 2011

TYVASO INHALATION SYSTEM

FDA Adverse Event
Malfunction ·UT GMBH·Product code CAF·July 1, 2013

OPTICROSS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·March 6, 2024

HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

FDA Adverse Event
Death ·HEARTWARE, INC.·Product code DSQ·July 27, 2023

EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDS·July 25, 2022

TRIMA ACCEL

FDA Adverse Event
Injury ·TERUMO BCT·Product code GKT·November 11, 2022

HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

FDA Adverse Event
Injury ·HEARTWARE, INC.·Product code DSQ·July 27, 2023

ECHELON 60

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 22, 2023

CONCERTO

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·December 7, 2022

PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAW·December 15, 2023