9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LDLC3 LDL-Cholesterol Gen.3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383507264·Gutta Percha Points is used to root canal filin...
BIOHORIZONS ABUTMENTS FOR ZIMMER
FDA 510(k)
FDA Class 2
·Dental
MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
FDA 510(k)
FDA Class 2
·Orthopedic
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·June 3, 2013
UNICEL® DXC 600 PRO SYNCHRON® SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC·Product code JJE·June 29, 2011
LIBERTE' CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code MAF·August 29, 2008
CR TIBIAL INSERT SZ3, 15MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 14, 2023
PKG, SCHERTEL FORCEPS, FENESTRATED, P/N 0250080312. 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