17 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DC-1 I.V. DOSAGE COMPUTER
FDA 510(k)
FDA Class 2
·Anesthesiology
RAD®
FDA UDI
MEDTRONIC XOMED, INC.·20681490047542·BLADE 1884016 RAD60 5PK EXTREME MAX
RAD
FDA UDI
MEDTRONIC XOMED, INC.·20763000518169·BLADE 1884016 RAD60 5PK EXTREME MAX
Reprocessed 4.0mm Rad 60 Curved Blade
FDA UDI
SURETEK MEDICAL·B3901884016·Reprocessed 4mm Rad 60 Curved Blade
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884016220·dentaform® Band, Tooth 46, Size 16/Roth 22
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884016180·dentaform® Band, Tooth 46, Size 16/Roth 18
Arthrex®
FDA UDI
ARTHREX, INC.·00888867047778·LO-PRO SCRW,SS 4.0X 16MMCANCLUS
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884016000·dentaform® Band, Tooth 46, Size 16
ASSERACHROM PROTEIN C KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GN BROTH
FDA 510(k)
FDA Class 1
·Microbiology
LO-PRO SCRW,SS 4.0X 16MMCANCLUS
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·February 26, 2020
LOW PROF SCRW,SS 4.0X 40MMCANN LNG THD
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·February 26, 2020
LOW PROF SCRW,SS 4.0X 35MMCANN LNG THD
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·February 26, 2020
ALARIS PUMP MODULE
FDA Adverse Event
Death
·CAREFUSION CORP·Product code FRN·June 11, 2014
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 14, 2010
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·December 21, 2012
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014