FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

51 results for "Secure BioMed Evaluations"
25–48 of 51
Search insights Median review: 120d Cleared: 100% Top manufacturer: Degen Medical Lead specialty: Orthopedic
Cleared Jun 07, 2023
Xenco Medical InterAlign Cervical Interbody System
K223059 · OVE
Xenco Medical, LLC
Orthopedic · 250d
Cleared Mar 17, 2023
DeGen Impulse AM™ System
K223418 · MAX
Degen Medical
Orthopedic · 127d
Cleared Nov 23, 2022
Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics...
K222967 · HWC
Avanti Orthopaedics, Inc.
Orthopedic · 57d
Cleared Aug 26, 2022
MedCAD AccuShape Titanium Patient-Specific Cranial Implant
K220357 · GXN
Medcad
Neurology · 199d
Cleared Jan 07, 2022
Cyclops™ Anterior Cervical Plate System
K213901 · KWQ
Degen Medical
Orthopedic · 24d
Cleared Dec 21, 2021
Xenco Medical Multilevel CerviKit
K213456 · KWQ
Xenco Medical, LLC
Orthopedic · 56d
Cleared Nov 24, 2021
ControlRad Select Model Z
K213455 · OWB
Controlrad, Inc.
Radiology · 29d
Cleared Aug 30, 2021
Impulse AM Interbody Fusion System
K210090 · MAX
Degen Medical
Orthopedic · 229d
Cleared Jul 29, 2021
FiteBac CC OrthoSeal
K210115 · DYH
Largent Health, LLC
Dental · 191d
Cleared Jul 16, 2021
Avanti Orthopaedics Ulnar Shortening System
K211592 · HRS
Avanti Orthopaedics, Inc.
Orthopedic · 53d
Cleared Jul 01, 2021
ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9
K211782 · OWB
Controlrad, Inc.
Radiology · 22d
Cleared Apr 02, 2021
DeGen Navigated Instrumentation
K203816 · OLO
Degen Medical
Orthopedic · 94d
Cleared Feb 12, 2021
MedCAD® AccuPlate® Patient-Specific Plate
K193280 · JEY
Medcad
Dental · 443d
Cleared Dec 23, 2020
ControlRad Select Model Z
K202431 · OWB
Controlrad, Inc.
Radiology · 120d
Cleared Dec 22, 2020
Impulse Interbody Fusion System
K201287 · MAX
Degen Medical
Orthopedic · 222d
Cleared Dec 10, 2020
Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral...
K200376 · OLO
Navbit Pty, Ltd.
Orthopedic · 296d
Cleared Oct 29, 2020
MedCAD® AccuPlan® System
K192282 · DZJ
Medcad
Dental · 434d
Cleared Oct 23, 2020
SURGIPHOR Wound Irrigation System
K202071 · FQH
Orthophor, LLC
General & Plastic Surgery · 88d
Cleared Jun 24, 2020
ControlRad Trace Model 9
K200663 · OWB
Controlrad, Inc.
Radiology · 103d
Cleared Apr 26, 2020
ControlRad Sterile Cover
K200238 · KKX
Controlrad, Inc.
General Hospital · 86d
Cleared Jan 23, 2020
FiteBac Cavity Cleanser
K190271 · LBH
Largent Health, LLC
Dental · 349d
Cleared Dec 13, 2019
Avanti Distal Radius and Forearm System
K191118 · HRS
Avanti Orthopaedics, Inc.
Orthopedic · 231d
Cleared Aug 30, 2019
Cyclops™ Anterior Cervical Plate System
K191786 · KWQ
Degen Medical, Inc.
Orthopedic · 58d
Cleared Jul 30, 2019
Addivation Medical Cervical Interbody System
K190291 · ODP
Addivation Medical, LLC
Orthopedic · 169d