FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
23953–23976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 2019
II-Type Intervertebral Spacer
K180228 · MAX
Paonan Biotech Co., Ltd.
Orthopedic · 350d
Cleared Jan 11, 2019
RESCAN 700, CALLISTO eye
K180229 · OBO
Carl Zeiss Meditec, AG
Ophthalmic · 350d
Cleared Jan 11, 2019
MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly
K180902 · CCK
Medipines Corporation
Anesthesiology · 280d
Cleared Jan 11, 2019
PROSTEP MICA Screw System
K181377 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 232d
Cleared Jan 11, 2019
AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)
K181649 · NVP
Trudell Medical International
Anesthesiology · 203d
Cleared Jan 11, 2019
UV Phototherapy
K181805 · FTC
Xuzhou Kernel Medical Equipment Co.,...
General & Plastic Surgery · 189d
Cleared Jan 11, 2019
MTA2.3 MATERIALS
K181917 · KIF
NuSmile, Ltd.
Dental · 178d
Cleared Jan 11, 2019
SLEEPAPP
K182202 · LRK
Comfort Acrylics, Inc.
Dental · 150d
Cleared Jan 11, 2019
Geo Staple System
K182212 · JDR
Gramercy Extremity Orthopedics, LLC
Orthopedic · 149d
Cleared Jan 11, 2019
Applied Tissue Technologies PWD™ Platform Wound Dressing
K182409 · OMP
Applied Tissue Technologies, LLC
General & Plastic Surgery · 129d
Cleared Jan 11, 2019
Senhance Ultrasonic System
K182421 · NAY
Transenterix, Inc.
General & Plastic Surgery · 128d
Cleared Jan 11, 2019
ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)
K182453 · NUV
I-Tech Industries Srl
General & Plastic Surgery · 126d
Cleared Jan 11, 2019
Catalyst CSR Press-Fit Humeral Components
K182500 · KWT
Catalyst Orthoscience, Inc.
Orthopedic · 121d
Cleared Jan 11, 2019
MULTIX Impact
K182517 · KPR
Siemens Medi Cal Solutions, Inc.
Radiology · 120d
Cleared Jan 11, 2019
Tamper Evident Cap with Male Luer Lock
K182545 · FPA
International Medical Industries, Inc.
General Hospital · 116d
Cleared Jan 11, 2019
CD Horizon™ Spinal System
K182928 · NQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 81d
Cleared Jan 11, 2019
DigitalDiagnost C90
K182973 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 77d
Cleared Jan 11, 2019
ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
K183031 · JWY
Biomerieux S.A.
Microbiology · 71d
Cleared Jan 11, 2019
uMR 580, uMR 588
K183137 · LNH
Shanghai United Imaging Healthcare...
Radiology · 59d
Cleared Jan 11, 2019
MTS Tetracycline 0.016 - 256 ug/mL
K183140 · JWY
Liofilchem S. R. L.
Microbiology · 59d
Cleared Jan 11, 2019
CereLink ICP Monitor, CereLink ICP Extension Cable
K183406 · GWM
Integra Lifesciences Corp.
Neurology · 32d
Cleared Jan 11, 2019
Roadrunner Extra Support Wire Guide
K183467 · DQX
Cook Incorporated
Cardiovascular · 28d
Cleared Jan 10, 2019
Advocate Non-Contact Infrared Thermometer
K180355 · FLL
Broadmaster Biotech, Corp.
General Hospital · 336d
Cleared Jan 10, 2019
Infrared Ear Thermometer
K180387 · FLL
Hetaida Technology Co., Ltd.
General Hospital · 332d