60 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS
FDA 510(k)
FDA Class 2
·Dental
COCAINE DIPSTICK TEST, MODEL D747-A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
FDA 510(k)
FDA Class 2
·Hematology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·October 6, 2011
RD SET YI
FDA Adverse Event
Malfunction
·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021
M-LNCS DC-I
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·November 21, 2016
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 28, 2011
M-LNCS DC-I
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·November 21, 2016
RADICAL-7
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·February 19, 2016
TRIAGE PROFILER SOB PANEL 25T
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code DAP·July 19, 2017
TRIAGE PROFILER SOB PANEL
FDA Adverse Event
Injury
·QUIDEL CARDIOVASCULAR INC.·Product code DAP·December 13, 2019
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 29, 2012
TRIAGE PROFILER SOB PANEL 25T
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHX·August 29, 2017
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 3, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code OYC·December 15, 2016
TRIAGE PROFILER SOB PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code GHH·March 4, 2021
UNIFY CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·April 26, 2013
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 7, 2011
PRECISION XTRA /OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITS UL·Product code NBW·July 21, 2008
TRIAGE PROFILER SOB PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR, INC.·Product code DAP·August 3, 2018