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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ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PRESTIGE LP™
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994493743·DISC 6972250 PRESTIGE
CONTOUR V-145AC
FDA Adverse Event
Death
·VENTRITEX, INC.·Product code LWS·June 26, 1997
SUPERCABLE GRIP AND PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY
FDA 510(k)
FDA Class 2
·Immunology
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CEC·April 23, 2012
GEM MICROVASCULAR ANASTOMOTIC COUPLER
FDA Adverse Event
Malfunction
·SYNOVIS SURGICAL INNOVATIONS·Product code MVR·February 15, 2013
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·January 21, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 31, 2014
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