15 results · 26ms · Sources: EU EUDAMED, US FDA

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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