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
17977–18000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 2021
Bio-C Repair Ion+
K201222 · KIF
Angelus Industria DE Produtos...
Dental · 281d
Cleared Feb 11, 2021
TRAUS SIP20
K201292 · EBW
Saeshin Precision Co., Ltd.
Dental · 273d
Cleared Feb 11, 2021
VORTRAN GO2VENT with PEEP Valve
K202219 · BTL
Vortran Medical Technology 1, Inc.
Anesthesiology · 189d
Cleared Feb 11, 2021
TenoTac Soft Tissue Fixation System
K203385 · MBI
Paragon 28, Inc.
Orthopedic · 85d
Cleared Feb 11, 2021
CATSmart, Automated Blood Processing Autotransfusion System
K210089 · CAC
Fresenius Kabi AG
Cardiovascular · 29d
Cleared Feb 10, 2021
Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)
K191897 · INI
Dongguan Prestige Sporting Goods Co.,...
Physical Medicine · 575d
Cleared Feb 10, 2021
Hi bebe super (Models BT-150S and BT-150L)
K200675 · HGX
Bistos Co., Ltd.
Obstetrics & Gynecology · 331d
Cleared Feb 10, 2021
Meditech ABPM-06 (BP6)
K201332 · DXN
Meditech , Ltd.
Cardiovascular · 267d
Cleared Feb 10, 2021
DSG Connect Technology
K201454 · PDQ
Spineguard S.A.
Neurology · 254d
Cleared Feb 10, 2021
Infrared Forehead Thermometer
K201536 · FLL
Hangzhou Qingyuan Medical Equipment...
General Hospital · 247d
Cleared Feb 10, 2021
Digital NeuroPort Biopotential Signal Processing System
K202174 · GWL
Blackrock Microsystems
Neurology · 190d
Cleared Feb 10, 2021
Standard Procedure Mask, Standard Surgical Mask
K202605 · FXX
Jiangsu Medplus Non-Woven...
General Hospital · 155d
Cleared Feb 10, 2021
FORE-SIGHT ELITE Absolute Tissue Oximeter
K203490 · MUD
Edwards Lifesciences, LLC
General & Plastic Surgery · 75d
Cleared Feb 10, 2021
SLENDERTONE Evolve Abs, Type 735
K203513 · NGX
Bio-Medical Research, Ltd.
Physical Medicine · 72d
Cleared Feb 10, 2021
EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing
K203557 · LPH
Encore Medical, L.P.
Orthopedic · 65d
Cleared Feb 10, 2021
da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X...
K203632 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 61d
Cleared Feb 09, 2021
SmartCT R1.0
K201583 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 243d
Cleared Feb 09, 2021
Concerto Versa, Detachable Coil
K202850 · KRD
Micro Therapeutics, Inc. d/b/a ev3...
Cardiovascular · 134d
Cleared Feb 09, 2021
Stryker PEEK Customized Cranial Implant Kit
K203055 · GWO
Stryker
Neurology · 124d
Cleared Feb 09, 2021
MR Conditional Sticky Pad Electrode
K203079 · GXY
Rhythmlink International, LLC
Neurology · 119d
Cleared Feb 09, 2021
Synapse 3D, Synapse 3D Base Tools v6.1
K203103 · LLZ
Fujifilm Corporation
Radiology · 118d
Cleared Feb 09, 2021
nPro Surgical Mask
K203265 · FXX
Np Medical, Inc.
General Hospital · 96d
Cleared Feb 09, 2021
Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7,...
K210083 · QEW
Penumbra, Inc.
Cardiovascular · 28d
Cleared Feb 09, 2021
LIAISON Anti-HAV
K210272 · LOL
DiaSorin, Inc.
Microbiology · 8d