83 results · 22ms · Sources: EU EUDAMED, 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