15 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY
FDA 510(k)
FDA Class 2
·Dental
artegral
FDA UDI
Merz Dental GmbH·D7091970205·anteriors; shade B3; mould CS
Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
FDA 510(k)
FDA Class 2
·Neurology
ZIOSTATION
FDA 510(k)
FDA Class 2
·Radiology
LIGASURE ADVANCE PISTOL GRIP
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·April 29, 2014
PROLIFT +M PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON INC·Product code OTP·February 20, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 25, 2011
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021
BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021
BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020
BD TRUCOUNT¿ TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025
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