341 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MRI AND CT SCANNERS
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code LNH·July 1, 2010
CHROMID STREPTO B AGAR
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code PQZ·November 1, 2017
CHROMID STREPTO B AGAR
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code PQZ·November 1, 2017
CHROMID® STRB AGAR
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code PQZ·March 2, 2018
CHROMID® STREPTO B AGAR
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code PQZ·June 18, 2018
Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal delivery in order to prevent infection of the neonate.
FDA Recall
Terminated
·Cardinal Health Inc.·Product code PQZ·April 20, 2020
PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751
FDA Recall
Open, Classified
·Biomerieux Inc·Product code PQZ·November 9, 2022
Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
FDA Recall
Terminated
·Hardy Diagnostics·Product code PQZ·October 6, 2020
Gbs Culture Media, Selective And Differential
FDA classification
FDA Class 1
·Gbs Culture Media, Selective And Differential
EMA 3D
FDA UDI
EMA SLEEP INCORPORATED·00850077473791·An intra oral appliance intended for mandibular...
KAVA DORSAL ACRYLIC
FDA UDI
APEX DENTAL SLEEP LAB INCORPORATED·00860008847508·A dental acrylic oral appliance intended for ma...
KAVA HERBST DUAL LAMINATE
FDA UDI
APEX DENTAL SLEEP LAB INCORPORATED·00860008847539·A Dental Dual laminate oral appliance intended ...
KAVA DORSAL DUAL LAMINATE
FDA UDI
APEX DENTAL SLEEP LAB INCORPORATED·00860008847522·A Dental Dual-Laminate oral appliance intended ...
KAVA HERBST ACRYLIC
FDA UDI
APEX DENTAL SLEEP LAB INCORPORATED·00860008847515·A custom acrylic oral appliance intended to sup...
PQ1
FDA 510(k)
FDA Class 2
·Dental
PQ1
FDA 510(k)
FDA Class 2
·Dental
PQ 1
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
Fehling Instruments GmbH & Co. KG·04058749114348·CERAMO HCR valve sciss. robust doub.-act., bl/b...
NA
FDA UDI
Fehling Instruments GmbH & Co. KG·04058749114324·CERAMO HCR valve forceps w. DeBakey-toothing,3....
NA
FDA UDI
Fehling Instruments GmbH & Co. KG·04058749119657·CERAMO HCR non-traum. forceps w. lock, str. 2.8...