11 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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FloNavi Open Field Fluorescence Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Mueller MStrips
FDA UDI
Mueller Sports Medicine, Inc.·00074676230474·M-STRIPS 1x3" BOX OF 100
Spinal Retractor
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896116238·Spinal Retractor With 40 Millimeter Deep Prongs
LEGION Inserts with JRNY Lock
FDA 510(k)
FDA Class 2
·Orthopedic
ADVISOR, MODEL 9200
FDA 510(k)
FDA Class 2
·Anesthesiology
EPIDURAL TRAY
FDA Adverse Event
Injury
·BUSSE HOSPITAL DISPOSABLES·Product code OGE·October 3, 2012
INFINITI VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·November 7, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 1, 2011
COULTER® LH 780 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 16, 2013
GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 2082844-002-01093489; 9) 2082844-002-01113262; 10) 2082844-002-01113711; 11) 2082844-002-01123085; 12) 2082844-002-01123918; 13) 2082844-002-01128966; 14) 2082844-002-01133042; 15) 2082844-002-01146447; 16) 2082844-002-100205; 17) 2082844-002-100749; 18) 2082844-002-100752; 19) 2082844-002-100995; 20) 2082844-002-101425; 21) 2082844-002-523548; 22) 2082844-002-529928; 23) 2082844-002-594800; 24) 2082844-002-643544; 25) 2082844-002-925841; 26) 2082844-002-965540; 27) 2082844-002-982916; 28) 2082844-002-983420; 29) 2082844-002-993905; 30) 2082844-002-995018; 31) 2082844-002-995799; 32) 2082844-002-998943; Radiant infant warmer
FDA Enforcement
Class I
·Completed·DATEX--OHMEDA, INC.·November 6, 2024
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020