32 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIRECT DIGITIZER REGIUS MODEL 370
FDA 510(k)
FDA Class 2
·Radiology
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00514181·
Epimed
FDA UDI
EPIMED INTERNATIONAL, INC·00818788020109·RX Coudé® Epidural Needle 18g TW x 3.5"
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756748810·Esophageal Stethoscope w/Temperature Sensor
ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S
FDA 510(k)
FDA Class 2
·Dental
ULTRAGUIDE MR-GUIDE 3000
FDA 510(k)
FDA Class 2
·Radiology
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
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
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
BIOMET BONE CEMENT R 40X1
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBB·January 12, 2017
BIOLOX DELTA INSERT 36MM 54-56MM SHELL
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·June 22, 2016
ALU FEM HEAD D32/0/5 42/12-14
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LZO·May 16, 2016
ALU FEM HEAD D32/-4/5 42/12-14
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LZO·May 16, 2016
TERUFLEX BLOOD BAG SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CORPORATION/TERUMO BCT·Product code KSR·April 10, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011
PERFIX PLUG
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·May 19, 2008
BIOLOX DELTA MODULAR CERAMIC HEAD
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code LZO·August 10, 2017