83 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMORAM/AGGRAM ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
TruForm
FDA UDI
Rmo, Inc.·00885797099587·MAX 1ST MOLAR RIGHT 92 BANDS
APOLLO
FDA UDI
Conmed Corporation·20653405051678·APOLLO Papillotome, Double Lumen, 8mm Beveled T...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197493031·GRUENBERG Tapered Blades
4x16mm...
ACL 9000 SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
HUMI-FLOW, MODEL 6-850-00/ 01/02
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
S5 CONTROL DISPLAY MODULE
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 8, 2012
S5 DOUBLE HEAD PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012
S5 DOUBLE HEAD PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012
Bone Grafting Material, Dental, With Biologic Component
FDA Pre-Market Approval
FDA Class 3
·INFUSE BONE GRAFT
S5 DOUBLE HEAD PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 29, 2012
S5 CONTROL DISPLAY MODULE
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012
S5 CONTROL PANEL
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 15, 2012
S5 CONTROL DISPLAY MODULE
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·April 10, 2013
RESTORE, ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 31, 2011
CAPSUREFIX
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 16, 2008
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·August 29, 2019
Bone Grafting Material, Dental, With Biologic Component
FDA Pre-Market Approval
FDA Class 3
·Infuse Bone Graft