15 results
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26ms
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Sources: EU EUDAMED, US FDA
NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CODMAN
FDA UDI
Cerenovus, Inc.·10886704040804·CODMAN Lumbar External Drainage Catheter With T...
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268217061·CUSTOM SURGICAL KIT VEIN PACK
HORIZONS HOT BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FORA V10 BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CODMAN LUMBAR EXTERNAL DRAINAGE KIT
FDA Adverse Event
Malfunction
·JOHNSON AND JOHNSON PROFESSIONAL, INC.·Product code JXG·June 16, 2016
CODMAN LUMBAR EXT DR CATH
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·December 16, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·May 20, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 6, 2012
SEALPTFE
FDA Adverse Event
Other
·VASCUTEK LTD.·Product code DSY·August 27, 2010
CODMAN LUMBAR CATHETER KIT
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·December 30, 2013
CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·December 27, 2013
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
FDA Enforcement
Class II
·Terminated·Arjo Hospital Equipment AB·October 15, 2014
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