15 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Nitrile Patient Examination gloves, Powderfree, Blue color
FDA 510(k)
FDA Class 1
·General Hospital
PERMOBIL M300 / M400
FDA 510(k)
FDA Class 2
·Physical Medicine
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·July 31, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 12, 2019
UNIV-BATTERY CHARGER F/SYNTHES BATT 4 CH
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code MOQ·October 6, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 3, 2013
GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN
FDA Adverse Event
Product code ECX·April 28, 2011
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 14, 2020
PKG, 3MM PEEK MULTI-FUNCTION HANDLE, P/N 0250282046 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
PKG, 10MM PEEK MONOPOLAR HANDLE, P/N 0250080618 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