7 results
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34ms
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Sources: EU EUDAMED, US FDA
FORMACLEAR- & MULTIPLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PROMEDICAL SURGICAL DRAPES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CYBREX LIDOCAINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 31, 2014
6.5MM CANCELLOUS BONE SCREW 32MM THREAD/70MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HRS·November 21, 2012
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·September 20, 2010
PKG, 5MM INSERT, BIOPSY FORCEPS, PUNCH, 45CM, P/N 0250080580 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