9 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AMISTEM H HA COATED STD STEM SIZE 5 LOT. 133067
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 29, 2021
PYLORI IGG
FDA 510(k)
FDA Class 1
·Microbiology
EXSALT SD7 WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
CORTSCR Ø4.5 L26 TI
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·May 29, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 18, 2011
IAB: 8 FR - 30 CC
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·August 22, 2008
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024