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
22753–22776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 2019
JKH Stimulator Plus
K191151 · NUH
Jkh USA, LLC
Neurology · 51d
Cleared Jun 21, 2019
FloPatch (FP110)
K191388 · DPW
Flosonics Medical (R/A 1929803...
Cardiovascular · 28d
Cleared Jun 21, 2019
Voyager Trajectory Array Guide (V-TAG)
K191400 · HAW
Mri Interventions, Inc.
Neurology · 28d
Cleared Jun 20, 2019
PK High Tibial Osteotomy Correction System
K182285 · KTW
Paonan Biotech Co., Ltd.
Orthopedic · 301d
Cleared Jun 20, 2019
DB-CMF
K182742 · GXP
Dimensional Bioceramics, LLC
Neurology · 265d
Cleared Jun 20, 2019
Powder Free Blue Nitrile Examination Gloves Tested for use with 32...
K183354 · LZA
Gx Corporation Sdn Bhd
General Hospital · 199d
Cleared Jun 20, 2019
EmBody System
K183450 · PBX
Inmode MD , Ltd.
General & Plastic Surgery · 190d
Cleared Jun 20, 2019
Panthera Dental Milled Bars
K183580 · NHA
Panthera Dental, Inc.
Dental · 181d
Cleared Jun 20, 2019
Kubtec Mozart (Xpert42)
K183624 · MWP
Kub Technologies, Inc.
Radiology · 176d
Cleared Jun 20, 2019
Powder-Free Clear Vinyl Patient Examination Gloves
K190095 · LYZ
Anhui Intco Medical Products Co., Ltd.
General Hospital · 149d
Cleared Jun 20, 2019
Renovis A200 PS Knee System as part of the Renovis A200 Knee System
K190122 · JWH
Renovis Surgical Technologies
Orthopedic · 146d
Cleared Jun 20, 2019
Soniquence Bipolar Electrodes
K190336 · GEI
Soniquence, LLC
General & Plastic Surgery · 126d
Cleared CT Jun 20, 2019
VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0
K190545 · NKB
Icotec AG
Orthopedic · 108d
Cleared Jun 20, 2019
Cepheid Xpert MRSA NxG Control Panel
K191172 · PMN
Microbiologics, Inc.
Microbiology · 50d
Cleared Jun 20, 2019
Campylobacter Chek
K191442 · LQP
Techlab, Inc.
Microbiology · 21d
Cleared Jun 20, 2019
Campylobacter Quik Chek
K191456 · LQP
Techlab, Inc.
Microbiology · 20d
Cleared Jun 19, 2019
Hailie Sensor
K182638 · CAF
Adherium (Nz), Ltd.
Anesthesiology · 268d
Cleared Jun 19, 2019
Bioliner
K182658 · NXC
Five Star Orthodontic Lab & Supply
Dental · 267d
Cleared Jun 19, 2019
EntericBio Dx Assay
K182703 · PCH
Serosep , Ltd.
Microbiology · 265d
Cleared Jun 19, 2019
Quidel Triage TOX Drug Screen, 94600
K182719 · DKZ
Quidel Cardiovascular, Inc.
Toxicology · 264d
Cleared CT Jun 19, 2019
STOP U (Packed Black USA), STOP U (Packed White USA)
K182774 · PAY
Pollogen, Ltd.
General & Plastic Surgery · 261d
Cleared Jun 19, 2019
LOQTEQ VA Foot Plates 2.5
K182785 · HRS
Aap Implantate AG
Orthopedic · 261d
Cleared Jun 19, 2019
MHD TENS
K190115 · NUH
Minghuangda Electronic Co., Ltd.
Neurology · 146d
Cleared Jun 19, 2019
RayStation
K190387 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 120d