9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
FORMATK MAGMA PLATFORM LASER
FDA Adverse Event
Injury
·FORMATK SYSTEMS LTD.·Product code GEX·December 19, 2019
NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY
FDA 510(k)
FDA Class 2
·Orthopedic
OWL CANNULAE
FDA 510(k)
FDA Class 2
·Neurology
FORMATK MAGMA PLATFORM
FDA Adverse Event
Malfunction
·FOMATK SYSTEMS, LTD·Product code GEX·January 8, 2020
INFINITY DENTAL IMPLANT SYSTEM
FDA Adverse Event
Injury
·ACE SURGICAL SUPPLY CO.·Product code DZE·June 5, 2013
AXSYM RUBELLA IGG ANTIBODY
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code LFX·September 10, 2008
CARDIOVASCULAR PROCEDURE KIT
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code OEZ·June 27, 2011
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023