8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DUFLEX CONFORMING BANDAGE (STERILE/NON-STERILE)
FDA 510(k)
FDA Unclassified
·Unknown
PRISMA UNIVERSAL BOND(R) 3
FDA 510(k)
FDA Class 2
·Dental
COMBO FETAL SCALP ELECTRODE/LEGPLATE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
FDA Adverse Event
Death
·MPRI·Product code LWS·February 6, 2013
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code FNL·December 27, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 21, 2014
SCRDRIVER SHAFT T8 CYLINDRIC W/GROOVE SH
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·May 6, 2022
PKG, FUNDUS FORCEPS, P/N 0250080315. 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