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

50 results for "BioVera, Inc."
1–24 of 50
Search insights Median review: 125d Cleared: 100% Top manufacturer: S.M.A.I.O Lead specialty: Orthopedic
Cleared Sep 04, 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K262828 · NKB
S.M.A.I.O
Orthopedic · 25d
Cleared Sep 01, 2026
SK Knee System
K253961 · JWH
Just Medical Devices (Tianjin) Co., Ltd.
Orthopedic · 265d
Cleared Aug 17, 2026
KBA3D (v2.4.0)
K261500 · LLZ
S.M.A.I.O
Radiology · 103d
Cleared Jul 01, 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K253802 · NKB
S.M.A.I.O
Orthopedic · 215d
Cleared May 28, 2026
BMD Titanium Spinal Fusion System
K253894 · MAX
Global Biomedica s.r.o.
Orthopedic · 175d
Cleared Apr 03, 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K260786 · NKB
S.M.A.I.O
Orthopedic · 24d
Cleared Jan 07, 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K253990 · NKB
S.M.A.I.O
Orthopedic · 26d
Cleared Dec 17, 2025
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K253721 · NKB
S.M.A.I.O
Orthopedic · 23d
Cleared Oct 01, 2025
Newclip Patient-matched instrumentation non sterile PSI
K250767 · PBF
Newclip Technics
Orthopedic · 202d
Cleared Jul 08, 2025
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K251804 · NKB
S.M.A.I.O
Orthopedic · 26d
Cleared May 02, 2025
Origin™ Cemented Hip Stem
K243043 · LZO
Signature Orthopaedics Pty, Ltd.
Orthopedic · 217d
Cleared Mar 11, 2025
Origin™ TT Stem
K243029 · LZO
Signature Orthopaedics Pty, Ltd.
Orthopedic · 165d
Cleared Feb 13, 2025
Newclip Patient-matched instrumentation non sterile PSI
K243912 · PBF
Newclip Technics
Orthopedic · 56d
Cleared Nov 27, 2024
BioBrace®
K242187 · OWW
Conmed Corporation
Orthopedic · 125d
Cleared Nov 06, 2024
Citrepore™
K240450 · MQV
Acuitive Technologies, Inc.
Orthopedic · 265d
Cleared Dec 22, 2023
Novae® Dual Mobility System, Hype® Hip System
K223745 · LZO
Serf
Orthopedic · 373d
Cleared Oct 25, 2023
Newclip Patient-matched instrumentation non sterile PSI
K221615 · PBF
Newclip Technics
Orthopedic · 509d
Cleared Sep 29, 2023
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K232650 · NKB
S.M.A.I.O
Orthopedic · 29d
Cleared May 30, 2023
KBA3D
K223841 · LLZ
S.M.A.I.O
Radiology · 159d
Cleared Feb 24, 2023
Ti-Largo Cervical Interbody System
K223231 · ODP
Flospine
Orthopedic · 129d
Cleared Jan 18, 2023
Uni-FuZe-C Bone Strip
K221726 · MQV
Zavation Medical Products, LLC
Orthopedic · 218d
Cleared Nov 04, 2022
Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and...
K220833 · MAI
Acuitive Technologies, Inc.
Orthopedic · 227d
Cleared Sep 30, 2022
Mg-PSZ Ceramic Femoral Head
K220336 · LPH
Theken Companies
Orthopedic · 235d
Cleared Jun 09, 2022
RedPoint Medical's Better Bunion System
K220717 · PBF
Redpoint Medical, LLC
Orthopedic · 90d