13 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ANNE Sleep
FDA 510(k)
FDA Class 2
·Anesthesiology
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869604307·MOSS Ti Rod, Ø5.5x95mm, straight
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869621359·MOSS VRS Ti rod, Ø5.5x95mm, straight
TenoTac Soft Tissue Fixation System
FDA UDI
Paragon 28, Inc.·00889795114532·STERILE-Female Implant, Long
SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Streamline Navigated Instruments
FDA 510(k)
FDA Class 2
·Neurology
GALILEO® LAG SCREW INSERTER
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HSB·May 22, 2024
TENACULUM FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GCJ·October 31, 2008
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 12, 2011
PROMOTE PLUS CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013
ARCHITECT CA 125 II
FDA Adverse Event
Injury
·ABBOTT LABORATORIES·Product code LTK·September 30, 2009
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025