22 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)
FDA 510(k)
FDA Class 2
·Hematology
LEONE SPA
FDA UDI
LEONE SPA·08033707018155·CALIBRA 1ST MOLAR BANDS n.LL 28
CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
MASIMO RADICAL Y PULSE CO-OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Widex
FDA UDI
Widex A/S·05706069897838·WIDEX EVOKE E-XP (Clay brown ) 30, Telecoil, RC...
RADICAL 7
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·December 18, 2014
RADICAL 7
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·December 18, 2014
RADICAL-7 COLOR SCREEN HANDHELD
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·May 29, 2015
UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHA·August 17, 2011
RDS3 DOCKING STATION
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·September 17, 2014
AMISTEM H HA COATED LAT STEM SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 7, 2018
SYNCHROMED II
FDA Adverse Event
Death
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·July 18, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 14, 2013
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008
OSTEO-SITE BONE BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK INC·Product code KNW·July 18, 2019
OSTEO-SITE BONE BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK INC·Product code KNW·June 17, 2019
OSTEO-SITE BONE BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK INC·Product code KNW·January 23, 2019
OSTEO-SITE BONE BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK INC·Product code KNW·July 16, 2019
OSTEO-SITE BONE BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK INC·Product code KNW·October 8, 2019
OSTEO-SITE BONE BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK INC·Product code KNW·July 17, 2019