22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISPOSABLE INSULIN SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306816307·Balfour Retractor, Open Ended Blades, 5cm Deep,...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450457870·
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K1104250·Tray, Base, 4.25", Arcamed
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1104250·Tray, 4.25 Inch Base
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON LABORATORIES, INC./HUNTINGTON·Product code HQL·October 20, 2006
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON LABORATORIES, INC / HUNTINGTON·Product code HQL·October 20, 2006
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·August 25, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013
LEAD MODEL 304
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·September 23, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·April 25, 2011
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·October 24, 2011
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 7, 2011
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
UNKNOWN·Product code FSA·July 30, 2012
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·May 30, 2012
ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·August 23, 2011
M2A-MAGNUM MOD HD SZ 50MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·December 31, 2018
Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·August 30, 2017