12 results
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20ms
·
Sources: EU EUDAMED, US FDA
REXTON RX34 WITH HORIZON PROGRAMMABLE OPTION
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ALKALINE PHOSPHATASE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CIBA CORNING ACS FT4 IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COBALT CHROME FEMORAL HEAD SZ 28 3.5MM 12/14 SHORT NECK
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JDI·December 15, 2016
COCR HEAD SHORT NECK DIA28/-3. 5 MM 12/14
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code JDI·May 10, 2016
BIOMET COBALT-CHROME FEMORAL COMPONENTS
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·March 17, 2017
COBALT CHROME FEMORAL HEAD
FDA Adverse Event
Death
·BIOMET FRANCE S.A.R.L.·Product code JDI·August 31, 2017
CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS
FDA Adverse Event
Malfunction
·SYNTHES·Product code HWB·January 15, 2013
UNKNOWN MIS TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·December 1, 2010
JUGGERKNOT 1.4MM 1 #1 MB 10PK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBI·July 7, 2014
BIOMET COBALT-CHROME FEMORAL COMPONENTS
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code JDI·April 7, 2017
PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080360. 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