10 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AMIKACIN
FDA 510(k)
FDA Class 2
·Microbiology
artegral
FDA UDI
Merz Dental GmbH·D7091970210·anteriors; shade B3; mould BOL
PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 29, 2014
PROMUS ELEMENT ¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·February 20, 2013
ACUITY
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·January 25, 2011
PUMP 371 14F LT CMR SET
FDA Adverse Event
Malfunction
·ABIOMED, INC. - 1220648·Product code OZD·January 20, 2026
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