11 results
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22ms
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Sources: EU EUDAMED, US FDA
CUP, DISPOSABLE MEDICINE
FDA 510(k)
FDA Class 1
·General Hospital
Ortho Specialties
FDA UDI
Young Innovations, Inc.·00840326414002·Bicuspid Bands, Upper, Size 17
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110645·COAXIAL IRR-ASP TIP STR W/SILICONE 0.4MM
POINTER EXCEL
FDA 510(k)
FDA Class 2
·Neurology
ARIES System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 21, 2014
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·September 26, 2012
UNK DEPUY INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 15, 2010
Minor/General/Ortho Pack, Kit number PSS3258, PSS3258(A, and PSS3258(B convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025