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

Filters: 2026–2026 ×
2,517 results
97–120 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Sep 24, 2026
corra® cervical plating system
K262149 · KWQ
Carlsmed, Inc.
Orthopedic · 91d
Cleared Sep 24, 2026
Pediatric Nailing Platform Femur
K261345 · HSB
OrthoPediatrics Corp.
Orthopedic · 154d
Cleared Sep 24, 2026
Electric Scooter (FNS01,FNS03)
K261078 · INI
Anhui Jbh Medical Apparatus Co., Ltd.
Physical Medicine · 176d
Cleared Sep 24, 2026
Disposable Belts for Polysomnography (CNSAC)
K260949 · MNR
CNSAC Medshop GmbH
Anesthesiology · 185d
Cleared Sep 24, 2026
MD-6000S Bladder Scanner
K260313 · IYO
MEDA Co., Ltd.
Radiology · 237d
Cleared Sep 24, 2026
STA® - Liquid Anti-Xa
K260214 · KFF
Diagnostica Stago, Inc.
Hematology · 244d
Cleared Sep 24, 2026
Align® Cover and Pad Guidance Tool
K260114 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 253d
Cleared Sep 24, 2026
KARL STORZ SUPRALOOP
K254303 · KNF
Karl Storz SE & CO. KG
Obstetrics & Gynecology · 267d
Cleared Sep 24, 2026
PicoreMax (PicoreMax)
K254199 · GEX
BLUECORE COMPANY Co., Ltd.
General & Plastic Surgery · 269d
Cleared Sep 23, 2026
SABER-C System
K263049 · OVE
Elevation Spine
Orthopedic · 23d
Cleared Sep 23, 2026
Electric wheelchair (GP100)
K262582 · ITI
Suzhou Green Pine Medical Co., Ltd.
Physical Medicine · 58d
Cleared Sep 23, 2026
BTL-299-F
K262353 · KPI
BTL Industries, Inc.
Gastroenterology & Urology · 75d
Cleared Sep 23, 2026
Hair Growth Comb (X-GC01)
K262254 · OAP
Guangdong Ashmore Health Technology...
General & Plastic Surgery · 83d
Cleared Sep 23, 2026
Cemented Plus Abutment
K262207 · NHA
Unidental Co., Ltd.
Dental · 85d
Cleared Sep 23, 2026
Anti-HCV Next
K262156 · MZO
Abbott Laboratories
Microbiology · 89d
Cleared Sep 23, 2026
DIAMED Handpiece
K262144 · EFB
SETAGAYA SEIKI Co., Ltd.
Dental · 90d
Cleared Sep 23, 2026
iFuse Granite Onyx™ Implant System
K262067 · NKB
SI-BONE, Inc.
Orthopedic · 93d
Cleared Sep 23, 2026
ProRib Fixation System
K261892 · HRS
Costa Surgical, Inc.
Orthopedic · 110d
Cleared Sep 23, 2026
Syneris PACS v.1.0.1.0
K261874 · LLZ
Syneris
Radiology · 110d
Cleared Sep 23, 2026
Single-use Flexible Bronchoscope
K261637 · EOQ
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 128d
Cleared Sep 23, 2026
G7® Acetabular System
K261453 · LPH
Zimmer Biomet
Orthopedic · 145d
Cleared Sep 23, 2026
Liquick X-treme, Liquick X-treme Plus
K261418 · EZD
Teleflex Medical
Gastroenterology & Urology · 146d
Cleared Sep 23, 2026
DynaNail Helix® Fixation System
K260995 · HWC
MedShape, Inc.
Orthopedic · 181d
Cleared Sep 23, 2026
VIRTUE QA
K260597 · LHN
ProNova Solutions
Radiology · 211d