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
12217–12240 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 2022
SafePort(TM) Manifold (or Stopcock)
K211204 · FMG
Elcam Medical Acal
General Hospital · 511d
Cleared Sep 15, 2022
MONDRIAN ALIF Cage with Supplementary Fixation Plate
K213641 · MAX
Ctl Medical Corporation
Orthopedic · 301d
Cleared Sep 15, 2022
Identity Shoulder System
K213856 · MBF
Zimmer, Inc.
Orthopedic · 279d
Cleared Sep 15, 2022
Elecsys AFP
K220176 · LOJ
Roche Diagnostics
Immunology · 237d
Cleared Sep 15, 2022
Nitrile Patient Examination Gloves, Powder Free
K220697 · LZA
Lalan Rubbers (Pvt), Ltd.
General Hospital · 190d
Cleared Sep 15, 2022
TrueBalance™ Surgical System
K220830 · ONN
These Three Medical, LLC
Orthopedic · 177d
Cleared Sep 15, 2022
P12 Elite Series Digital Color Doppler Ultrasound System
K221089 · IYN
Sonoscape Medical Corp.
Radiology · 155d
Cleared Sep 15, 2022
Diamond Air+ (UI04A, UI04B, UI04C)
K221553 · OHT
Ulike Co., Ltd.
General & Plastic Surgery · 107d
Cleared Sep 15, 2022
CO2 Laser System
K221597 · GEX
Smedtrum Medical Technology Co., Ltd.
General & Plastic Surgery · 105d
Cleared Sep 15, 2022
NovoSorb Matrix
K221686 · QSZ
Polynovo Biomaterials Pty, Ltd.
General & Plastic Surgery · 97d
Cleared Sep 15, 2022
Dynamic TiBase
K221966 · NHA
Talladium Espana, SL
Dental · 72d
Cleared Sep 15, 2022
StageOne™ Shoulder Cement Spacer Molds
K221968 · MBB
Biomet, Inc.
Orthopedic · 72d
Cleared Sep 15, 2022
ArcTO Transobturator Sling System
K222468 · OTN
Urocure, LLC
Gastroenterology & Urology · 30d
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