17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REBILDA SC
FDA 510(k)
FDA Class 2
·Dental
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756136082·Airway Circuit
Medline/MMS Sales
FDA UDI
MEDLINE INDUSTRIES, INC.·10884389061121·CIRCUIT-PEDIATRIC ANESTHESIA
Medline/MMS Sales
FDA UDI
MEDLINE INDUSTRIES, INC.·10080196985142·CIRCUIT-PEDIATRIC ANESTHESIA
Medline/MMS Sales
FDA UDI
MEDLINE INDUSTRIES, INC.·10884389006399·CIRCUIT-PEDIATRIC ANESTHESIA
CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
TENDRIL ST
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011
RIGID INJECTION NEEDLE - STRAIGHT
FDA Adverse Event
Other
·BIOFORM MEDICAL, INC.·Product code GAA·March 13, 2008
3I T3® WITH DCD® TAPERED IMPLANT 4/3 X 8.5MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·September 12, 2022
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·November 8, 2024
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Death
·HEARTWARE, INC.·Product code DSQ·November 8, 2024
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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022
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