14 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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GETINGE 800HC- SERIES STEAM STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
Nichamin Hydrodissection Cannula, 25ga
FDA UDI
KATALYST SURGICAL LLC·00840096205664·Nichamin Hydrodissection Cannula, 25ga
VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03
FDA 510(k)
FDA Class 2
·Anesthesiology
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
FDA 510(k)
FDA Class 2
·Microbiology
LINEAR 7.5 FR. 25CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019
LINEAR 7.5 FR. 25CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019
COMP RVS HMRL TI TRAY 44MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·May 21, 2013
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DIP·June 14, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 20, 2008
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Injury
·ANGIOSCORE, INC·Product code LIT·March 29, 2016
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Malfunction
·ANGIOSCORE, INC·Product code LIT·November 26, 2015
SENSATION PLUS 7.5FR. 40CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 23, 2021
SENSATION PLUS 7.5FR. 40CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·January 4, 2022
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024