14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MectaLIF Anterior Extension
FDA 510(k)
FDA Class 2
·Orthopedic
MECTALIF ANT - LAG
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074362205·SCREW 7221545 HA COATED CANN 5.5 X 45
Sklar®
FDA UDI
SKLAR CORPORATION·10649111005480·OPER SCISS DEL CRV S/B 4 1/2"
BONESCALPEL 20MM UNILATTERAL SERRATIONS BLADE
FDA Adverse Event
Malfunction
·MISONIX INC·Product code LFL·August 14, 2018
G-Jet® Transgastric-Jejunal Feeding Device
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071102784·22FR x 1.5 cm x 45 cm Low Profile Transgastric-...
BELLYBOARD, SBRT ACCESSORIES
FDA 510(k)
FDA Class 2
·Radiology
Surgical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
G-Jet® Transgastric-Jejunal Feeding Device
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071117528·22FR x 1.5 cm x 45 cm Low Profile Transgastric-...
7600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 5, 2008
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·August 24, 2011
DUROM FEMORAL COMPONENT 52 CODE R
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·July 9, 2013
i-CAT Classic (X-Ray Tube head and Power Supply) X-Ray imaging device that constructs a three dimensional model from images taken during a rotational X-Ray sequence. Intended to be used whenever a dentist, oral surgeon or other physician needs 3D information of high contrast objects.
FDA Recall
Terminated
·Imaging Sciences International, LLC·Product code JAK·December 15, 2010
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025