FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

64 results for "Secure BioMed Evaluations"
49–64 of 64
Search insights Median review: 117d Cleared: 100% Top manufacturer: Degen Medical Lead specialty: Orthopedic
Cleared Jul 30, 2019
Addivation Medical Cervical Interbody System
K190291 · ODP
Addivation Medical, LLC
Orthopedic · 169d
Cleared Aug 13, 2018
KLS Martin Individual Patient Solutions
K180962 · JEY
KLS-Martin L.P.
Dental · 123d
Cleared Jul 19, 2018
Latitud Hip Replacement System
K172857 · LPH
Meril Healthcare Pvt. , Ltd.
Orthopedic · 302d
Cleared Jan 29, 2018
DeGen Medical E3 MIS Pedicle Screw System
K173814 · NKB
Degen Medical
Orthopedic · 45d
Cleared Nov 30, 2017
Destiknee™ Total Knee System
K172936 · JWH
Meril Healthcare Pvt. , Ltd.
Orthopedic · 65d
Cleared Nov 27, 2017
Cerafix Dura Substitute
K172603 · GXQ
Acera Surgical, Inc.
Neurology · 89d
Cleared Apr 26, 2017
Restrata Wound Matrix
K170300 · QSZ
Acera Surgical, Inc.
General & Plastic Surgery · 85d
Cleared Aug 08, 2016
Cerafix Dura Substitute
K161278 · GXQ
Acera Surgical, Inc.
Neurology · 94d
Cleared Jun 28, 2016
F1 MPS Modular Pedicle Screw System
K160926 · NKB
Degen Medical
Orthopedic · 85d
Cleared Mar 16, 2016
Cerafix Dura Substitute
K153613 · GXQ
Acera Surgical, Inc.
Neurology · 90d
Cleared Dec 15, 2015
Latitude-C Cervical Interbody Spacer System
K151496 · ODP
Degen Medical
Orthopedic · 195d
Cleared Aug 12, 2015
SI-TECHNOLOGY® SI-DESIS® SCREWS
K151462 · OUR
Si-Technology, LLC
Orthopedic · 72d
Cleared Jul 28, 2015
Hyper-C Anterior Cervical Plate System
K150759 · KWQ
Degen Medical
Orthopedic · 127d
Cleared May 29, 2015
opti-Toe
K142478 · HTY
Graham Medical Technologies, LLC...
Orthopedic · 268d
Cleared Mar 20, 2015
F1-Modular Pedicle Screw System
K142531 · NKB
Degen Medical
Orthopedic · 192d
Cleared Oct 03, 2014
HyProCure II
K142534 · HWC
Graham Medical Technologies, LLC Dba...
Orthopedic · 24d