10 results · 20ms · Sources: EU EUDAMED, US FDA

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Disposable ureteral stent

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GOMCO

FDA UDI
Allied Medical, LLC·00026072001974·ASPIRATOR-SURGICAL -UTERINE

Ultrasound System 2300

FDA 510(k)
FDA Class 2 ·Radiology

Home use hair removal device, model: Precise Touch Pro

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·November 9, 2023

ACCOLADE HFX STEM SIZE 4

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS MAHAWAH·Product code KWY·November 24, 2008

INRATIO2

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 29, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 23, 2013

PKG, GRASPER FORCEP, BOWEL, P/N 0250080324. 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

ACCOLADE DR SL MRI (Model L311)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025