10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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