FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
12505–12528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 2022
AIR OPTIX COLORS
K222500 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 28d
Cleared Sep 14, 2022
FINDER G6PD
K201049 · JBF
Baebies, Inc.
Hematology · 876d
Cleared Sep 14, 2022
iRelieve Microcurrent Pain Relief System
K212618 · GZJ
Fast Track Technologies, Inc.
Neurology · 392d
Cleared Sep 14, 2022
V-HEPES PLUS
K213293 · MQL
Vitromed Langenfeld
Obstetrics & Gynecology · 348d
Cleared Sep 14, 2022
SavvyWire
K213854 · DQX
Opsens, Inc.
Cardiovascular · 278d
Cleared Sep 14, 2022
Tornier Perform Humeral System – Stemless
K220418 · PKC
Tornier, Inc.
Orthopedic · 212d
Cleared Sep 14, 2022
TSX Implants
K220978 · DZE
Biomet 3i, LLC
Dental · 163d
Cleared Sep 14, 2022
SprintRay Denture Base
K220979 · EBI
Sprintray, Inc.
Dental · 163d
Cleared Sep 14, 2022
Qorda QD1
K220990 · FRF
Winix, Inc.
General Hospital · 163d
Cleared Sep 14, 2022
SafeSept® Transseptal Guidewire (SS-140)
K221707 · DRC
Pressure Products Medical Device...
Cardiovascular · 93d
Cleared Sep 14, 2022
Solea
K221761 · NVK
Convergent Dental, Inc.
Dental · 89d
Cleared Sep 14, 2022
BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes...
K221797 · JAQ
Varian Medical Systems, Inc.
Radiology · 85d
Cleared Sep 14, 2022
GEM Biover Microvascular Clamps
K221843 · DXC
Synovis Micro Companies Alliance, Inc.
Cardiovascular · 82d
Cleared Sep 14, 2022
Arthrex SoftStitch
K222078 · GAT
Arthrex, Inc.
General & Plastic Surgery · 62d
Cleared Sep 14, 2022
Grappler Suture Anchor System
K222091 · MBI
Paragon 28, Inc.
Orthopedic · 61d
Cleared Sep 14, 2022
WatchPAT300 (WP300)
K222331 · MNR
Itamar Medical , Ltd.
Anesthesiology · 43d
Cleared Sep 14, 2022
Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
K222503 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 27d
Cleared Sep 14, 2022
LightForce Orthodontic System
K222764 · NJM
Lightforce Orthodontics
Dental · 1d
Cleared Sep 13, 2022
MagiCath II
K210929 · FOZ
Woo Young Medical Co., Ltd.
General Hospital · 533d
Cleared Sep 13, 2022
Simplexa COVID-19 Direct
K212147 · QQX
Diasorin Molecular, LLC
Microbiology · 431d
Cleared Sep 13, 2022
Female IC (Not Finalized)
K213575 · EZD
Hollister Incorporated
Gastroenterology & Urology · 307d
Cleared Sep 13, 2022
SP-CL Hip Stem and LCU Hip System
K213770 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 285d
Cleared Sep 13, 2022
LAITEST Medical Face Mask
K214035 · FXX
R&R Medical Corporation, Ltd.
General Hospital · 264d
Cleared Sep 13, 2022
Solid State X-ray Imager(Model: FXRD-4386WB)
K220239 · MQB
Vieworks Co., Ltd.
Radiology · 228d