10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ORBSCAN
FDA 510(k)
FDA Class 2
·Ophthalmic
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984443·anteriors; shade C1; mould 96
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756048255·Bias Stockinette 4In X 3YD4/Pk 25Pk/Cs
PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE
FDA 510(k)
FDA Class 2
·Radiology
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013
FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET
FDA Adverse Event
Injury
·COOK, INC.·Product code GBX·February 1, 2011
DEXTRUS 4137
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·August 6, 2014
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM F/IM NAIL-STER
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·December 1, 2023
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024