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
22465–22488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 2019
STATCLAVE G4 Chamber Autoclave
K190062 · FLE
Scican , Ltd.
General Hospital · 192d
Cleared Jul 26, 2019
Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask,...
K190533 · CBK
Sleepnet Corporation
Anesthesiology · 144d
Cleared Jul 26, 2019
Hair Growth System
K190685 · OAP
Xuzhou Kernel Medical Equipment Co.,...
General & Plastic Surgery · 130d
Cleared Jul 26, 2019
Infrared Ear/Forehead Thermometer
K190873 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 114d
Cleared Jul 26, 2019
ScanX Barrier Envelopes
K190949 · PEM
Air Techniques, Inc.
General & Plastic Surgery · 106d
Cleared Jul 26, 2019
Megadyne Foot Switch
K191328 · FYD
Megadyne Medical Products, Inc.
General Hospital · 71d
Cleared Jul 26, 2019
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
K191396 · CJY
HORIBA ABX SAS
Chemistry · 63d
Cleared Jul 26, 2019
ASAHI Neurovascular Guide Wire CHIKAI X 014 soft
K191714 · MOF
Asahi Intecc Co., Ltd.
Neurology · 30d
Cleared Jul 26, 2019
The ZIP Accessory Shuttle for PleuraFlow System
K191733 · OTK
Clearflow, Inc.
General & Plastic Surgery · 28d
Cleared Jul 26, 2019
da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30
K191736 · NAY
Intuitive Surgical
General & Plastic Surgery · 28d
Cleared Jul 26, 2019
Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex...
K191777 · JAK
Ge Medical Systems, LLC
Radiology · 24d
Cleared Jul 26, 2019
ActivOrtho Continuous Compression Screw System
K191817 · HWC
Activortho, Inc.
Orthopedic · 21d
Cleared Jul 25, 2019
Maxima Electric System
K180845 · EBW
Handpiece Headquarters - Hpr, Inc.
Dental · 479d
Cleared Jul 25, 2019
Galilei G6 Lens Professional
K182659 · MXK
Sis Ag, Surgical Instrument Systems
Ophthalmic · 303d
Cleared Jul 25, 2019
Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer
K183017 · JWH
Osteoremedies, LLC
Orthopedic · 267d
Cleared Jul 25, 2019
The POWERWAND Safety Introducer with an Extended Dwell Catheter made of...
K183066 · DYB
Access Scientific, LLC
Cardiovascular · 262d
Cleared Jul 25, 2019
Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable...
K183249 · MAX
Stryker Spine
Orthopedic · 246d
Cleared Jul 25, 2019
Passio Pump Drainage System
K190292 · DWM
Bearpac Medical
Anesthesiology · 164d
Cleared Jul 25, 2019
RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant
K190774 · MBI
Medos International SARL
Orthopedic · 121d
Cleared Jul 25, 2019
Silicone PHMB Foam Wound Dressing
K190819 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 115d
Cleared Jul 25, 2019
PrisMax System Version 2
K190910 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 108d
Cleared Jul 25, 2019
Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires
K191173 · NTE
Abbott Vascular
Cardiovascular · 85d
Cleared Jul 25, 2019
JOURNEY II Unicompartmental Knee System
K191211 · HSX
Smith & Nephew, Inc.
Orthopedic · 80d
Cleared Jul 25, 2019
Stonetome Stone Removal Device
K191789 · LQR
Boston Scientific Corporation
Gastroenterology & Urology · 22d