761 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VESICA PERC STABILIZATION KIT WITH PROTEGEN SLING
FDA Adverse Event
Injury
·MICROVASIVE UROLOGY/A DIVISION OF BOSTON SCIENTIFIC CORP.·Product code FKH·July 10, 2002
MESA LABORATORIES 7.0 PH SOLUTION
FDA Adverse Event
Malfunction
·MESA LABORATORIES·Product code FKH·October 3, 2013
MESA LABORATORIES 7.0 PH SOLUTION
FDA Adverse Event
Malfunction
·MESA LABORATORIES INC·Product code FKH·October 2, 2013
MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02.0027). Polyethylene bottle Conductivity/TDS Calibrator solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS measurement instruments. The conductivity/TDS cells and instruments may be indicated for calibrating the conductivity measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the hemodialysis machine or water purification equipment, and do not come into contact with the patient.
FDA Recall
Terminated
·Mesa Laboratories, Inc.·Product code FKH·May 12, 2017
Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters
FDA Recall
Open, Classified
·NIPRO Technical Services, Inc.·Product code FKH·December 12, 2025
Solution-Test Standard-Conductivity, Dialysis
FDA classification
FDA Class 2
·Solution-Test Standard-Conductivity, Dialysis
FKG DENTAIRE SARL
FDA registration
FKG DENTAIRE SARL·9 products·🇨🇭 Switzerland
FKA Distributing Co., LLC
FDA registration
FKA Distributing Co., LLC·13 products·🇺🇸 United States
FKA Distributing Co., LLC
FDA registration
FKA Distributing Co., LLC·20 products·🇺🇸 United States
JKH Health Co., Ltd.
FDA registration
JKH Health Co., Ltd.·22 products·🇨🇳 China
HUDSON RCI
FDA UDI
TELEFLEX INCORPORATED·04026704581474·HUMID-VENT FILTER LIGHT W/SOFT FLEX
HUDSON RCI
FDA UDI
TELEFLEX INCORPORATED·14026704659248·HUMID-VENT®, Compact, Straight w/ SOFTFLEX
HUDSON RCI
FDA UDI
TELEFLEX INCORPORATED·14026704659330·HUMID-VENT FILTER LIGHT W/SOFT FLEX
Hudson RCI
FDA UDI
TELEFLEX INCORPORATED·14026704644862·HUMID-VENT®, Compact, Straight w/ SOFTFLEX
GIBECK
FDA UDI
TELEFLEX INCORPORATED·14026704734181·HUMID-VENT®, Compact, Straight w/ SOFTFLEX
HEARING AID MODEL F8H ANL F8T
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MEDCURA, INC. (FKA GEL-E, INC.)
FDA registration
MEDCURA, INC. (FKA GEL-E, INC.)·1 product·🇺🇸 United States
Sonablate Corp. (FKA) SonaCare Medical, LLC
FDA registration
Sonablate Corp. (FKA) SonaCare Medical, LLC·1 product·🇺🇸 United States
BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WIDEX HEARING AID MODEL F7H & F7T
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat