184 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ROMA (HE4 EIA + ARCHITECT CA 125 II)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TARTAR REMOVER FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896052895·TARTAR REMOVER FORCEPS LARGE SIZE TUNGSTEN CARB...
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828154246·GEN4 Direct Access
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973530·
DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)
FDA 510(k)
FDA Class 2
·Radiology
AMISTEM H CEMENTLESS STEM SIZE 2 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·December 11, 2014
STEM: AMISTEM H HA COATED STD STEM SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 31, 2020
VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 4, 2019
VERSAFITCUP CC TRIO ACETABULAR SHELL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 3, 2017
AMISTEM H, HA COATED STEM SIZE 5 STD
FDA Adverse Event
Death
·MEDACTA INTERNATIONAL SA·Product code LZO·September 20, 2017
AMISTEM H FEMORAL CEMENTLESS STEM SIZE 3 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·December 12, 2013
QUADRA-S CEMENTLESS, SAND BLASTED LAT STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JDI·July 29, 2015
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·July 11, 2019
VERSAFITCUP CC CUP IMPACTOR
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL, SA·Product code LXH·November 21, 2014
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·December 2, 2019
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·March 18, 2020
VERSAFITCUP ACETABULAR SHELL CC TRIO Ø 56
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 9, 2018
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 9, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 19, 2014