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
24697–24720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2018
TNI softFlow 50
K180474 · BTT
Tni Medical AG
Anesthesiology · 238d
Cleared Oct 18, 2018
Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit...
K180708 · PIF
Xeridiem Medical Devices, A Spectrum...
Gastroenterology & Urology · 213d
Cleared Oct 18, 2018
Extended Lipid Panel Assay
K181373 · CHH
Laboratory Corporation of America...
Chemistry · 147d
Cleared Oct 18, 2018
Reprocessed Torqr Diagnostic EP Catheter
K181618 · NLH
Innovative Health, LLC
Cardiovascular · 121d
Cleared Oct 18, 2018
BD FlowSmart Set/MiniMed Pro-Set
K181718 · FPA
Becton, Dickinson and Company
General Hospital · 111d
Cleared Oct 18, 2018
Medax Biopsy Systems III
K181803 · KNW
Medax Srl Unipersonale
General & Plastic Surgery · 105d
Cleared Oct 18, 2018
Swift System
K181941 · NEY
Emblation , Ltd.
General & Plastic Surgery · 90d
Cleared Oct 18, 2018
Quantum Ventilation Module
K181942 · DTX
Spectrum Medical , Ltd.
Cardiovascular · 90d
Cleared Oct 18, 2018
QuickScreen Pro Multi Drug Screening Test, Model 9395Z
K181945 · DKZ
Phamatech, Inc.
Toxicology · 90d
Cleared Oct 18, 2018
OLYMPIC Posterior Spinal Fixation System
K182239 · NKB
Astura Medical, LLC
Orthopedic · 59d
Cleared Oct 18, 2018
14HK701G-W
K182348 · MQB
Lg Electronics.Inc
Radiology · 50d
Cleared Oct 18, 2018
Spectralis HRA+OCT and variants with High Magnification Module
K182569 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 30d
Cleared Oct 18, 2018
RadiForce RX360, RX360-AR
K182591 · PGY
Eizo Corporation
Radiology · 28d
Cleared Oct 17, 2018
ELAN 4 Electro Motor System Tools
K172709 · HBE
Aesculap, Inc.
Neurology · 404d
Cleared Oct 17, 2018
Full Automatic(NIBP) Blood Pressure Monitor
K180240 · DXN
Health & Life Co., Ltd.
Cardiovascular · 261d
Cleared Oct 17, 2018
Uroject12 Syringe Lever
K180345 · QBL
Urogen Pharma, Ltd.
Gastroenterology & Urology · 251d
Cleared Oct 17, 2018
Ortho System
K180941 · PNN
3Shape A/S
Dental · 203d
Cleared Oct 17, 2018
OsteoBridge™ IDSF System
K181026 · HSB
Merete GmbH
Orthopedic · 182d
Cleared Oct 17, 2018
Muscle Trainer
K181728 · NGX
Shenzhen Kentro Medical Electronics...
Physical Medicine · 110d
Cleared Oct 17, 2018
Arterys MICA
K182034 · LLZ
Arterys, Inc.
Radiology · 79d
Cleared Oct 17, 2018
PASS LP Spinal System
K182240 · NKB
Medicrea International SA
Orthopedic · 58d
Cleared Oct 17, 2018
Alphenix, INFX-8000H/B, V8.0
K182546 · OWB
Canon Medical Systems Corporation
Radiology · 30d
Cleared Oct 17, 2018
Wireless Digital Flat Panel Detector
K182550 · MQB
Iray Technology Taicang , Ltd.
Radiology · 30d
Cleared Oct 17, 2018
Wireless Digital Flat Panel Detector
K182551 · MQB
Iray Technology Taicang , Ltd.
Radiology · 30d