11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J
FDA 510(k)
FDA Class 2
·Cardiovascular
MASTER & FRANK SURGICAL GOWNS (STERILE)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VASCULAR ASSIST
FDA 510(k)
FDA Class 2
·Cardiovascular
PASS LP - LIAPASS
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013
EVOLUT FX DCS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 1, 2025
ENPULSE DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·April 16, 2013
EON MINI IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 17, 2011
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code FTL·June 13, 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012