11 results
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22ms
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Sources: EU EUDAMED, US FDA
MEDTRONIC GRAFT DELIVERY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
BIPOLAR IRRIGATION FORCEPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5
FDA 510(k)
FDA Class 2
·Ophthalmic
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 4, 2019
DISCOVERY ULNA 3X115MM RT W/BEARING C
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDC·April 17, 2013
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code MUZ·June 18, 2008
MX-PRO R-3 AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·April 11, 2011
AXON ECLIPSE CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·October 4, 2013
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
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