63 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CHILI VIDEO, CHILI VIDEOPRO
FDA 510(k)
FDA Class 2
·Radiology
PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PRIMORIS HIP STEM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·August 5, 2016
DELTA CER FEM HD 32/+3MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·July 21, 2016
BIOLOX DELTA MODULAR CERAMIC HEAD 32MM STANDARD NECK TYPE 1 TAPER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·October 18, 2016
PRIMORIS FEMORAL STEM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·October 3, 2017
PRIMORIS NECK PROSTH BM SZ 26
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·August 4, 2016
PRIMORIS HIP STEM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·August 5, 2016
BIOLOX DELTA MODULAR CERAMIC HEAD 32MM STANDARD NECK TYPE 1 TAPER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·October 18, 2016
BIOLOX DELTA MODULAR CERAMIC HEAD 32MM STANDARD NECK TYPE 1 TAPER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·October 18, 2016
DELTA CERAMIC FEM HD DIA36/ 0MM 12/14
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·August 2, 2016
PRMRS NCK STEM TI BM SZ 24 RSA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·June 23, 2016
TAPERLOC LAT COCR 10MM T1
FDA Adverse Event
Death
·BIOMET UK LTD.·Product code JDI·March 20, 2026
TPRLOC COCR CMTD STEM T1 7.5MM
FDA Adverse Event
Death
·BIOMET UK LTD.·Product code JDI·March 20, 2026
UNKNOWN PRIMORIS HIP
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·August 4, 2016
ALU FEM HD D28/+3.5/5 42/12-14
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LZO·June 17, 2016
PRMRS NCK STEM TI BM SZ 24 RSA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWY·April 13, 2018
Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Ambler Surgical brand name.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·December 17, 2014
Y-KNOT ALL SUTURE ANCHOR DRILL BIT
FDA Adverse Event
Malfunction
·CONMED LINVATEC·Product code GFG·April 10, 2013