20 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T
FDA 510(k)
FDA Class 2
·Cardiovascular
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458761·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130140·Sagittal Bender, Right
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458747·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458730·
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01308N0·Cervical Rasp, 14 x 11, 8mm, 0 Degree, No Taper
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458778·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458754·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458716·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458723·
REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP
FDA 510(k)
FDA Class 2
·Neurology
CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012
FDA 510(k)
FDA Class 2
·Cardiovascular
TAXUS® LIBERTÉ®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·March 20, 2013
ARTICULEZE BALL 28 +1.5 GR
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·February 24, 2011
MAXCEM ELITE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·August 15, 2014
EMBRYO RPLCMNT CATHETER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code MQF·September 24, 2019
ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 7, 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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·March 27, 2024