12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GAMBRO POLYFLUX, MODEL 140H, 170H, 210H
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KATOR, LLC
FDA UDI
KATOR, LLC·B18610305920·KATOR Suture Anchor, Arthroscopic, 5.0mm x 25mm...
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120305921·Diamond, cone round, medium grit
AQUA WATER TREATMENT FOR HEMODIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET
FDA 510(k)
FDA Class 2
·General Hospital
COMPLETE DOUBLE MOIST
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code LPN·October 14, 2014
BD VACUTAINER® WINGED SAFETY PBBCS WITH TUBING
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code JKA·December 28, 2017
PINNACLE SECTOR II CUP 58MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·April 2, 2013
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 9, 2011
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·April 15, 2008
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Death
·HEARTWARE, INC.·Product code DSQ·October 19, 2020
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012