10 results
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18ms
·
Sources: EU EUDAMED, US FDA
HFT750U
FDA 510(k)
FDA Class 2
·Anesthesiology
ELLUME COVID-19 HOME TEST
FDA Adverse Event
Malfunction
·ELLUME LIMITED·Product code QKP·January 4, 2022
Disposable Trocar
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TUF LINK SILICONE RELINER
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 2, 2025
TRIADYNE II THERAPY SYSTEM
FDA Adverse Event
Injury
·KCI USA, INC.·Product code IKZ·November 21, 2008
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 23, 2013
PKG, 5MM INSERT, ATRAUMATIC GRASPER FORCEPS, DOUBLE ACTION 45CM, P/N 0250080585 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016