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
12481–12504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 2022
GelPOINT V-Path Vaginal Access System
K220969 · MOK
Applied Medical Resources Corporation
Obstetrics & Gynecology · 165d
Cleared Sep 16, 2022
OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion...
K221074 · GEI
Stryker Corporation
General & Plastic Surgery · 157d
Cleared Sep 16, 2022
LEDEX
K221194 · EBZ
Dentmate Technology Co. , Ltd.
Dental · 144d
Cleared Sep 16, 2022
L1P-1F (TRIOS 5)
K221249 · NBL
3Shape TRIOS A/S
Dental · 137d
Cleared Sep 16, 2022
ECHELON ENDOPATH Staple Line Reinforcement
K221343 · OXC
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 130d
Cleared Sep 16, 2022
Surgical Face Masks (Ear Loops And Tie-On)
K221534 · FXX
San-M Package Co., Ltd.
General Hospital · 112d
Cleared Sep 16, 2022
Exsalta
K221676 · BTA
Drw Medical
General & Plastic Surgery · 99d
Cleared Sep 16, 2022
Electric Wheelchair, Model: 9000N
K221799 · ITI
Silver Fox Corporation Limited
Physical Medicine · 87d
Cleared Sep 16, 2022
Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket...
K222155 · PNR
Jiangsu Caina Medical Co.,Ltd
Gastroenterology & Urology · 58d
Cleared Sep 16, 2022
ClearPoint System
K222519 · HAW
ClearPoint Neuro, Inc.
Neurology · 28d
Cleared Sep 15, 2022
Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
K203336 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 672d
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