FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
7129–7152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 2024
1060nm laser body slimming machine
K240658 · PKT
Hebei JT Medical Co., Ltd.
General & Plastic Surgery · 66d
Cleared May 13, 2024
Brainomix 360 e-Lung
K233875 · JAK
Brainomix Limited
Radiology · 158d
Cleared May 13, 2024
MIM – Monte Carlo Dosimetry
K232862 · LLZ
Mim Software, Inc.
Radiology · 241d
Cleared May 13, 2024
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with...
K232614 · LZA
Sri Trang Gloves (Thailand) Public...
General Hospital · 259d
Cleared May 13, 2024
Disposable Double Lumen Endobronchial Tube
K232529 · CBI
Shenzhen Insighters Medical...
Anesthesiology · 266d
Cleared May 13, 2024
BEAR 2 Body
K232242 · NFO
Foreo, Inc.
Neurology · 290d
Cleared May 10, 2024
Organic Cotton Tampon
K240708 · HEB
Suzhou Borage Medical Technology Co.,...
Obstetrics & Gynecology · 56d
Cleared May 10, 2024
SCARLET® AC-Ti
K240699 · OVE
Spineart SA
Orthopedic · 57d
Cleared May 10, 2024
Dochek® Multi-Drug Urine Test Dipcard Rx
K240698 · DJG
Guangzhou Decheng Biotechnology Co.,...
Toxicology · 57d
Cleared May 10, 2024
Access OV Monitor
K240479 · LTK
Beckman Coulter, Inc.
Immunology · 80d
Cleared May 10, 2024
Ureterorenoscope System
K240374 · FGB
Shenzhen HugeMed Medical Technical...
Gastroenterology & Urology · 93d
Cleared May 10, 2024
Bioceramic Root Repair Material (C-Root BP)
K240365 · KIF
Beijing C-Root Dental Medical Devices...
Dental · 94d
Cleared May 10, 2024
PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader...
K240276 · NEZ
Given Imaging Ltd. (D.B.A. Medtronic)
Gastroenterology & Urology · 100d
Cleared May 10, 2024
HyperSuture Extension Line
K234079 · GAT
Threadstone, LLC
General & Plastic Surgery · 140d
Cleared May 10, 2024
Oocyte Flushing & Retrieval Medium
K234023 · MQL
Gimbo Medical Technology Shenzhen...
Obstetrics & Gynecology · 142d
Cleared May 10, 2024
pureFLOW 402 (F00012067)
K233950 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 148d
Cleared May 10, 2024
APERTO Lucent MRI System
K233629 · LNH
Fujifilm Healthcare Americas Corporation
Radiology · 179d
Cleared May 10, 2024
Filter Needle for Single Use
K233277 · FPB
Hangzhou Qiantang Longyue...
General Hospital · 224d
Cleared May 10, 2024
QIAstat-Dx® Respiratory Panel Plus
K233100 · QOF
QIAGEN GmbH
Microbiology · 227d
Cleared May 10, 2024
Aerogen®Solo Nebulizer System
K232507 · CAF
Aerogen, Ltd.
Anesthesiology · 266d
Cleared May 10, 2024
Disposable infusion set with needle
K232475 · FPA
Shandong Zhushi Pharmaceutical Group...
General Hospital · 268d
Cleared May 10, 2024
SmartChest
K232410 · QFM
Milvue
Radiology · 274d
Cleared May 09, 2024
Flexible Fixation Device for Gynecological Applicators (GM11001960)
K240495 · JAQ
Varian Medical Systems, Inc.
Radiology · 79d
Cleared May 09, 2024
Access BR Monitor
K240403 · MOI
Beckman Coulter, Inc.
Immunology · 90d