9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EzDent-i / E2 / Prora View/ Smart M Viewer
FDA 510(k)
FDA Class 2
·Radiology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197080392·CASTROVIEJO Micro Needle Holder
145mm,...
LANX SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
FDA 510(k)
FDA Class 2
·Cardiovascular
PLUS SL
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPEDICS AG·Product code KWY·November 5, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 24, 2011
MX40 1.4 GHZ SMART HOPPING
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DSI·July 2, 2013
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025