22 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dental Implants OKTAGON Tissue Level and Bone Level
FDA 510(k)
FDA Class 2
·Dental
VERTE-STACK SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS
FDA 510(k)
FDA Class 2
·General Hospital
Centric-T
FDA UDI
Life Spine, Inc.·00190837090203·TAP, ø7.5MM X 45MM
Centric-T
FDA UDI
Life Spine, Inc.·00190837090180·TAP, ø7.5MM X 25MM
Centric-T
FDA UDI
Life Spine, Inc.·00190837090128·TAP, ø4.5MM X 45MM
Centric- T
FDA UDI
Life Spine, Inc.·00190837089351·
Centric-T
FDA UDI
Life Spine, Inc.·00190837090104·TAP, ø4.5MM X 25MM
Centric-T
FDA UDI
Life Spine, Inc.·00190837090135·TAP, ø5.5MM X 25MM
Centric-T
FDA UDI
Life Spine, Inc.·00190837090173·TAP, ø6.5MM X 45MM
Centric-T
FDA UDI
Life Spine, Inc.·00190837090142·TAP, ø5.5MM X 45MM
Centric-T
FDA UDI
Life Spine, Inc.·00190837090166·TAP, ø6.5MM X 35MM
Centric-T
FDA UDI
Life Spine, Inc.·00190837090197·TAP, ø7.5MM X 35MM
Centric-T
FDA UDI
Life Spine, Inc.·00190837090159·TAP, ø6.5MM X 25MM
WEREWOLF RF 20000 CONTROLLER
FDA Adverse Event
Malfunction
·ARTHROCARE CORP.·Product code GEI·June 29, 2020
RESOLUTE INTEGRITY RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·October 10, 2014
OPEN SPINE CLAMP, TITANIUM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 11, 2013
SYNERGY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·July 12, 2011
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026