9 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INTRAORAL MANDIBULAR DISTRACTION DEVICE
FDA 510(k)
FDA Class 2
·Dental
artegral
FDA UDI
Merz Dental GmbH·D7091970256·anteriors; shade B4; mould UBM
EMIT THEOPHYLLINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CATHETERS, SILICONE COATED
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INFUSOMAT SPACE - US VERSION
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·February 12, 2013
COMPRESSION ANASTOMOSIS RING (CAR 27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·January 14, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·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