10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
JR MEDIC Nitrile Examination Gloves Powder Free- Black
FDA 510(k)
FDA Class 1
·General Hospital
BD BBL™ Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX™)
FDA UDI
BECTON, DICKINSON AND COMPANY·10382902211690·BD BBL™ Chocolate II Agar (GC II Agar with Hemo...
Bronchoscope System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MICROSTREP PLUS PANEL, AZITHROMYCIN
FDA 510(k)
FDA Class 2
·Microbiology
ASPHERE M SPEC 12/14 36 +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·November 3, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 24, 2011
SELEX/MAGNUM MODULAR HEAD 40MM -3
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LZO·July 11, 2013
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·May 12, 2020
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020