26 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDIANT
FDA UDI
INTELLIGENT IMPLANT SYSTEMS, LLC·00814033021273·Mediant 2.0 mm Drill Guide
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515016569·Mayo Hegar N.H., 9"
Cervical Interbody 13mm x 12mm x 9mm Packaging
FDA UDI
XENCO MEDICAL LLC·B064XM11213091·Cervical Interbody 13mm x 12mm x 9mm
MDT Diamond Coated Dental Burs
FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·17291046340155·Rotary diamond instrument for dental application
MDT Diamond Coated Dental Burs
FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·17291046364670·Rotary diamond instrument for dental application
MDT Diamond Coated Dental Burs
FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·17291046340162·Rotary diamond instrument for dental application
MDT Diamond Coated Dental Burs
FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·17291046364663·Rotary diamond instrument for dental application
EXELINT ALUMINUM HUB BLUNT NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
DIGITAL RADIOGRAPHY
FDA 510(k)
FDA Class 2
·Radiology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·March 26, 2022
TENDRIL DX
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 13, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 13, 2011
BRYAN® CERVICAL DISC SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MJO·May 29, 2012
INSPIRE 8F DUAL
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·January 9, 2026
INSPIRE 6 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES
FDA Adverse Event
SORIN GROUP ITALIA S.R.L.·Product code DTZ·December 7, 2016
Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2)
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code LLZ·October 8, 2004
Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019
ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·November 21, 2018