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

Filters: Cleared only ×
174,955 results
10465–10488 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 2023
BIASURGE Advanced Surgical Solution
K223377 · FRO
Rochal Technologies, LLC
General & Plastic Surgery · 146d
Cleared Mar 30, 2023
Emory Cardiac Toolbox 4.3
K223422 · KPS
Syntermed
Radiology · 136d
Cleared Mar 30, 2023
Medartis APTUS® Ulna Plates
K223853 · HRS
Medartis AG
Orthopedic · 97d
Cleared Mar 30, 2023
HOPKINS Telescopes
K223923 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 90d
Cleared Mar 30, 2023
ONLINE TDM Phenytoin - Free Phenytoin application
K230161 · MOJ
Roche Diagnostics
Chemistry · 69d
Cleared Mar 30, 2023
Cemented Tibia Baseplate no Taper with JRNY Lock
K230555 · JWH
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Mar 30, 2023
ARDO Bellis
K230590 · HGX
Ardo Medical AG
Obstetrics & Gynecology · 27d
Cleared Mar 30, 2023
Maestro Microcatheter
K230636 · KRA
Merit Medical System, Inc.
Cardiovascular · 23d
Cleared Mar 29, 2023
EndoDrill® Model X
K212423 · FCG
Bibbinstruments AB
Gastroenterology & Urology · 602d
Cleared Mar 29, 2023
SiJoin®T3
K213815 · OUR
Vgi Medical, Inc.
Orthopedic · 477d
Cleared Mar 29, 2023
InterView XP
K221984 · LLZ
Mediso Medical Imaging Systems, Lttd.
Radiology · 266d
Cleared Mar 29, 2023
RayStation 12A
K222312 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 240d
Cleared Mar 29, 2023
KLS Martin Level One Rib Fixation System
K222397 · HRS
KLS-Martin L.P.
Orthopedic · 233d
Cleared Mar 29, 2023
SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser
K222485 · GEX
Ids, Limited
General & Plastic Surgery · 224d
Cleared Mar 29, 2023
Stethophone v1
K222871 · DQD
Sparrow Acoustics, Inc.
Cardiovascular · 188d
Cleared Mar 29, 2023
Trevo NXT ProVue Retriever
K223305 · POL
Stryker Neurovascular
Neurology · 153d
Cleared Mar 29, 2023
Calibrate LTX Interbody System
K223611 · MAX
Alphatec Spine, Inc.
Orthopedic · 117d
Cleared Mar 29, 2023
Tactoset
K223915 · MQV
Anika Therapeutics, Inc.
Orthopedic · 90d
Cleared Mar 29, 2023
PUMA-G System
K223916 · KGC
Coaptech, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 29, 2023
ROSA® Knee System
K230243 · OLO
Orthosoft D/B/A Zimmer Cas
Orthopedic · 58d
Cleared Mar 29, 2023
WishBone Medical Plate and Screw System
K230527 · HRS
Wishbone Medical, Inc.
Orthopedic · 30d
Cleared Mar 28, 2023
Carestation 750/750c
K213867 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 473d
Cleared Mar 28, 2023
X-Y Lubricating Jelly
K220226 · NUC
R&R Medical Corporation, Ltd.
Obstetrics & Gynecology · 425d
Cleared Mar 28, 2023
DTX Studio Clinic 3.0
K221921 · MYN
Nobel Biocare AB
Radiology · 270d