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
5329–5352 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 2024
MicroTrend System
K212425 · CCK
Exostat Medical, Inc.
Anesthesiology · 1191d
Cleared Nov 06, 2024
BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel)
K243222 · QDS
Biofire Diagnostics, LLC (Biomerieux)
Microbiology · 30d
Cleared Nov 06, 2024
Compound W Skin Tag Remover
K242803 · GEH
Medtech Products, Inc.
General & Plastic Surgery · 50d
Cleared Nov 06, 2024
ELEXIR 2.0 (ALLIVE3)
K242719 · PCC
Nu Eyne Co., Ltd.
Neurology · 57d
Cleared Nov 06, 2024
Agility Symmetric™ Total Knee System
K242412 · MBH
Medisurge, LLC
Orthopedic · 84d
Cleared Nov 06, 2024
Accelx Implant System
K242261 · DZE
Biotech Dental, LLC
Dental · 98d
Cleared Nov 06, 2024
Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB,...
K242039 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 117d
Cleared Nov 06, 2024
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
K240997 · DQX
Abbott Medical
Cardiovascular · 209d
Cleared Nov 06, 2024
MultiCut Solo
K240831 · GCJ
Asclepion Laser Technologies GmbH
Obstetrics & Gynecology · 225d
Cleared Nov 06, 2024
Citrepore™
K240450 · MQV
Acuitive Technologies, Inc.
Orthopedic · 265d
Cleared Nov 05, 2024
CarboClear® Hybrid Pedicle Screw System
K243106 · NKB
CarboFix Orthopedics , Ltd.
Orthopedic · 36d
Cleared Nov 05, 2024
Skyway Anterior Cervical Plate System
K243015 · KWQ
Kyocera Medical Technologies, Inc.
Orthopedic · 39d
Cleared Nov 05, 2024
FreedomFlow™ Orbital Circumferential Atherectomy System
K242947 · MCW
Cardio Flow Inc.,
Cardiovascular · 41d
Cleared Nov 05, 2024
gentleheel® Adult Incision Device
K242664 · FMK
Gri-Alleset, Inc.
General & Plastic Surgery · 62d
Cleared Nov 05, 2024
Delphi Stimulator
K242345 · GWF
Quantalx Neuroscience
Neurology · 90d
Cleared Nov 05, 2024
DESS Dental Smart Solutions
K242340 · NHA
Terrats Medical SL
Dental · 90d
Cleared Nov 05, 2024
Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341,...
K242332 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 90d
Cleared Nov 05, 2024
MEDRAD Centargo CT Injection System
K241849 · IZQ
Imaxeon Pty, Ltd.
General Hospital · 131d
Cleared Nov 05, 2024
Atlas™ Humeral Nail System
K241484 · HSB
Orthopedic Designs North America,...
Orthopedic · 165d
Cleared Nov 05, 2024
TeraRecon Cardiac.Chambers.MR (1.0.0)
K241312 · QIH
Terarecon,Inc.
Radiology · 180d
Cleared Nov 05, 2024
InfuLife
K240624 · MEB
First Medical Source, LLC
General Hospital · 245d
Cleared Nov 05, 2024
POTENZA
K231287 · GEI
Jeisys Medical, Inc.
General & Plastic Surgery · 551d
Cleared Nov 04, 2024
SonoStik Guide Wire Introducer
K243061 · DYB
Sonostik, LLC
Cardiovascular · 38d
Cleared Nov 04, 2024
JLK-PWI
K242709 · LLZ
JLK, Inc.
Radiology · 56d