9 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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