10 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121
FDA 510(k)
FDA Class 2
·Clinical Toxicology
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0430210·Sagittal Bender, Double Ended Right
INTRAUTERINE DELIVERY SYSTEM - INJECTOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NANMA ADJUSTABLE CONSTRICTION RING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIM·January 28, 2011
HOMEPUMP ECLIPSE: 400 ML, 100 ML/HR
FDA Adverse Event
Malfunction
·I-FLOW CORP.·Product code MEB·March 7, 2013
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 25, 2011
FINELINE II
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
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
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018