15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WU'S 4-WHEELED NEO SCOOTER, WT-M4JR
FDA 510(k)
FDA Class 2
·Physical Medicine
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496032489·PERSONALITY 70 SHEER, SIZE 4XXL, CAMEL, GRADUAT...
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032489·Baltic Denture System BDLoad ↓ Mn6 PLSEum2DFm C...
ACE Surgical Silk Bb 4-0 18" Ds18
FDA UDI
Surgical Specialties México, S. de R.L. de C.V.·00848782022793·003-2489 Silk Bb 4-0 18" Ds18
PS CONSTRAINED INSERT XLG
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·July 20, 2017
MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10
FDA 510(k)
FDA Class 2
·Cardiovascular
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DA VINCI ROBOTICS SYSTEM
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC.·Product code NAY·October 21, 2003
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code OTN·April 3, 2013
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·March 29, 2011
BD NEXIVA CLOSED IV ACCESS SYSTEM
FDA Adverse Event
Other
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·April 16, 2008
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
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
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012