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
23713–23736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 15, 2019
PREVENA RESTOR(TM) Incision Management System
K181507 · OMP
Kci USA, Inc.
General & Plastic Surgery · 253d
Cleared Feb 15, 2019
CIRRUS HD-OCT
K181534 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 249d
Cleared Feb 15, 2019
OsseOne Dental Implant System
K182293 · DZE
Synoross Dba Osseone
Dental · 175d
Cleared Feb 15, 2019
PhantomMSK
K182332 · LLZ
OrthoGrid Systems, Inc.
Radiology · 171d
Cleared Feb 15, 2019
RS85 Diagnostic Ultrasound System
K182932 · IYN
Samsung Medison Co., Ltd.
Radiology · 116d
Cleared Feb 15, 2019
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder...
K183039 · KWS
Stryker GmbH
Orthopedic · 106d
Cleared Feb 15, 2019
Reliance Lumbar IBF System
K183049 · MAX
Reliance Medical Systems, LLC
Orthopedic · 105d
Cleared Feb 15, 2019
EndoFLIP System
K183072 · FFX
Crospon, Ltd.
Gastroenterology & Urology · 102d
Cleared Feb 15, 2019
3M Comply Hydrogen Peroxide Indicator Tape
K183209 · JOJ
3M Company
General Hospital · 88d
Cleared Feb 15, 2019
IPL Hair Removal Device
K183217 · OHT
Touchbeauty Beauty & Health...
General & Plastic Surgery · 88d
Cleared Feb 15, 2019
MAGNETOM Terra
K183222 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 87d
Cleared Feb 15, 2019
Stabil Orthopaedic Solutions Total Knee System
K183225 · JWH
Stabil Orthopaedic Solutions, LLC
Orthopedic · 87d
Cleared Feb 15, 2019
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
K183324 · JWY
Thermo Fisher Scientific
Microbiology · 77d
Cleared Feb 15, 2019
oCare Wrist Pulse Oximeter
K183556 · DQA
Taiwan Biophotonic Corporation
Anesthesiology · 57d
Cleared Feb 15, 2019
MAGNETOM Aera
K190138 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 17d
Cleared Feb 14, 2019
Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing,...
K181315 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 272d
Cleared Feb 14, 2019
GMC Wrist Automatic Blood Pressure Monitor
K181930 · DXN
Gmc, Inc.
Cardiovascular · 211d
Cleared Feb 14, 2019
Ion Endoluminal System
K182188 · EOQ
Intuitive Surgical
Ear, Nose, Throat · 185d
Cleared Feb 14, 2019
DynaNail Mini
K182677 · HWC
MedShape, Inc.
Orthopedic · 141d
Cleared Feb 14, 2019
Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups
K182705 · LZO
B-One Ortho, Corp.
Orthopedic · 140d
Cleared Feb 14, 2019
MyoStrain 5.1
K182756 · LNH
Myocardial Solutions
Radiology · 139d
Cleared Feb 14, 2019
Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
K183063 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 101d
Cleared Feb 14, 2019
Shoreline Cervical Interbody RT System
K183083 · ODP
SeaSpine Orthopedics Corporation
Orthopedic · 100d
Cleared Feb 14, 2019
Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy...
K183196 · OLO
Stryker Corporation
Orthopedic · 87d