29 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CLINISTRIP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Urine Reagent Strips (URS) 11 Parameters URS-11-100G-001 510(K) number: K970250 Devise Listing number: D072377 Each Device consists of 100 strips of Urine Reagent Strips 11 parameters packed with a desiccant pouch inside a black bottle with Cortez Diagnostics Label on the bottle and the bottle placed inside a Cortez Diagnostics Box.
FDA Recall
Terminated
·Teco Diagnostics·Product code KQO·October 14, 2011
Urine Reagent Strips (URS) 10 Parameters URS-l0-100W 510(K) number: K970250 Devise Listing number: D072377 Each device consists of 100 strips of Urine Reagent Strips 10 parameters packed with a desiccant pouch inside a gray bottle with Teco Diagnostics Label on the bottle and the bottle placed inside a Teco Diagnostics Box. For the semi-quantitative and qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes in urine.
FDA Recall
Terminated
·Teco Diagnostics·Product code KQO·October 14, 2011
artegral
FDA UDI
Merz Dental GmbH·D7091970250·anteriors; shade B4; mould ITS
MH
FDA UDI
Mazza Healthcare LLC·10850018327975·CSR Wrap Closure Tape, 2.5cm x 50m, non-sterile
NUTRITONE FACIAL BEAUTY SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
SmartTarget
FDA 510(k)
FDA Class 2
·Radiology
BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 1, 2026
BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 27, 2026
BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 18, 2026
BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·April 21, 2026
BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 18, 2026
BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·April 23, 2026
BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·April 22, 2026
BD VACUTAINER® SERUM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·December 10, 2025
BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 5, 2026
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 20, 2013
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
KENSTONE METAL·Product code INM·July 31, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 25, 2011
BD VACUTAINER® SERUM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·December 18, 2025