10 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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EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
artegral
FDA UDI
Merz Dental GmbH·D7091970290·anteriors; shade C2; mould CL
Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr
FDA 510(k)
FDA Class 1
·General Hospital
SPI VECTODRILL CERAMIC DRILLS
FDA 510(k)
FDA Class 1
·Dental
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRB·April 14, 2021
S-ROM*SLVE ZTTOVSZ 20F-SML18ID
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code LPH·February 20, 2013
MULTI-LUMEN CVC KIT: 3-L 7 FR X 8 (20 C
FDA Adverse Event
Injury
·ARROW INTERNATIONAL INC·Product code FOZ·January 14, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·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