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
11401–11424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 2022
Inogen Rove 4 Portable Oxygen Concentrator
K222086 · CAW
Inogen
Anesthesiology · 147d
Cleared Dec 09, 2022
Swang-Ganz IQ pulmonary artery catheter
K222117 · DYG
Edwards Lifesiences, LLC
Cardiovascular · 144d
Cleared Dec 09, 2022
FloPatch FP120
K222242 · DPW
Flosonics Medical
Cardiovascular · 136d
Cleared Dec 09, 2022
120V Neptune S Rover (0711-001-000)
K222552 · JCX
Stryker Instruments
General & Plastic Surgery · 108d
Cleared Dec 09, 2022
Stryker Cutomized Mandible Recon Plate
K222650 · JEY
Stryker Craniomaxillofacial (Cmf)
Dental · 99d
Cleared Dec 09, 2022
SeaSpine 7D Navigation Instruments
K222753 · OLO
SeaSpine Orthopedics Corporation
Orthopedic · 88d
Cleared Dec 09, 2022
US 450 Diode Laser Equipment
K222916 · GEX
Beijing Globalipl Development Co., Ltd.
General & Plastic Surgery · 74d
Cleared Dec 09, 2022
AIROS 8P Sequential Compression Device
K223193 · JOW
Airos Medical, Inc.
Cardiovascular · 57d
Cleared Dec 09, 2022
AIROS 6P Sequential Compression Device
K223195 · JOW
Airos Medical, Inc.
Cardiovascular · 57d
Cleared Dec 09, 2022
CELLO II Balloon Guide Catheter
K223275 · QJP
Fuji Systems Corporation
Neurology · 46d
Cleared Dec 09, 2022
HemosIL von Willebrand Factor Antigen
K223402 · GGP
Instrumentation Laboratory CO
Hematology · 30d
Cleared Dec 09, 2022
LIAISON Anti-HAV
K223403 · LOL
DiaSorin, Inc.
Microbiology · 30d
Cleared Dec 08, 2022
Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer,...
K211800 · LGZ
Quality IN Flow , Ltd.
General Hospital · 546d
Cleared Dec 08, 2022
Oxygen Concentrator, Model JAY-5AW
K213210 · CAW
Longfian Scitech Co., Ltd.
Anesthesiology · 435d
Cleared Dec 08, 2022
Sleeved IC
K220667 · EZD
Hollister Incorporated
Gastroenterology & Urology · 276d
Cleared Dec 08, 2022
LED Curing Light
K220826 · EBZ
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 261d
Cleared Dec 08, 2022
Southern Transforaminal Lumbar Interbody Fusion (TLIF)
K221182 · MAX
Southern Medical (Pty) , Ltd.
Orthopedic · 227d
Cleared Dec 08, 2022
LED Eye Perfector, model: EY-36A, EY-36B
K221444 · OHS
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 204d
Cleared Dec 08, 2022
YY-A02-B Overlapped Compression Therapy
K221862 · IRP
Huizhou Xinyi Technology Co., Ltd.
Physical Medicine · 164d
Cleared Dec 08, 2022
CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System
K222038 · QNR
Abbott (Formerly Thoratec Corporation)
Cardiovascular · 150d
Cleared Dec 08, 2022
IRRAflow Active Fluid Exchange System (AFES)
K222471 · JXG
Irras USA
Neurology · 114d
Cleared Dec 08, 2022
Yomi Robotic System
K222750 · QRY
Neocis, Inc.
Dental · 87d
Cleared Dec 08, 2022
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser...
K222837 · MCW
Spectranetics, Inc.
Cardiovascular · 79d
Cleared Dec 08, 2022
MAVERICK Mini External Fixation System
K223112 · JDW
Smith & Nephew, Inc.
Orthopedic · 66d