14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NextDent Ortho Flex
FDA 510(k)
FDA Unclassified
·Unknown
FareTec PST
FDA UDI
FARETEC, INC.·B54122210220·FareTec PST, Civilian with basket clamps, no case.
SIMPLEX/SARAL
FDA UDI
PARAMOUNT SURGICALS, INC.·00852647007757·1 LEVEL CERVICAL PLATE 22 MM
PLIF/TLIF/Oblique Inserter
FDA UDI
XENCO MEDICAL LLC·B064XM12210221·
Tizian Blank 5.0 translucent
FDA UDI
Pritidenta GmbH·04251366905997·
HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)
FDA 510(k)
FDA Class 2
·Hematology
AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AMS RETROARC RETROPUBIC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS (MN)·Product code OTN·November 3, 2014
TAXUS (R) LIBERTÉ (R)
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·August 23, 2011
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES,INC·Product code MIH·July 5, 2013
8015 ALARIS SYSTEM PC UNIT
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·February 9, 2021
13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.
FDA Enforcement
Class II
·Terminated·Cairn Diagnostics·February 24, 2021
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020