15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYS*STIM 206 (MODEL-ME 206)
FDA 510(k)
FDA Class 2
·Physical Medicine
Easytouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18601072·EasyTouch Infrared Thermometer
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981127152·14x13x7mm, 7 Degree Trial
Unimed
FDA UDI
Unimed Medical Supplies, Inc.·06936735487127·EEG Patient Interface Cable EEG Patient Interfa...
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860107000·Standard Band, Tooth 15-14/24-25, Size 7
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860107180·Standard Band, Tooth 15-14/24-25, Size 7/Roth 18
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860107220·Standard Band, Tooth 15-14/24-25, Size 7/Roth 22
DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
BIS
FDA Adverse Event
Malfunction
·JABIL CIRCUIT SINGAPORE PTE LTD·Product code OLW·June 3, 2025
BIS
FDA Adverse Event
Malfunction
·JABIL CIRCUIT SINGAPORE PTE LTD·Product code OLW·June 3, 2025
ATTAIN OTW
FDA Adverse Event
Malfunction
·MPRI·Product code LWP·June 10, 2014
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·November 21, 2012
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 20, 2010
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012