11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ASAHI AM-R SERIES DIALYZERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
artegral
FDA UDI
Merz Dental GmbH·D7091970650·anteriors; shade A3.5 light; mould BIS
Orthofix TrueLok Hexapod System (TL-HEX) V2.0
FDA 510(k)
FDA Class 2
·Orthopedic
PRE-DUCED CULTURE MEDIA
FDA 510(k)
FDA Class 1
·Microbiology
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRB·April 14, 2021
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·February 19, 2021
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·June 2, 2014
UNKNOWN DEPUY STEM
FDA Adverse Event
Malfunction
·DEPUY WARSAW·Product code KWA·February 20, 2013
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM DE MEXICO S DE RL DE CV·Product code FPO·January 18, 2011
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