FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
7465–7488 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 2024
Overjet Caries Assist-Pediatric
K233738 · MYN
Overjet, Inc.
Radiology · 103d
Cleared Mar 04, 2024
Vyvo
K231288 · DQA
Vyvo Technology Corp.(Vt)
Anesthesiology · 305d
Cleared Mar 04, 2024
Medical Diode Laser Systems
K230047 · NVK
Gigaalaser Company , Ltd.
Dental · 423d
Cleared Mar 01, 2024
MiroDry Wound Matrix
K240277 · KGN
Reprise Biomedical, Inc.
General & Plastic Surgery · 30d
Cleared Mar 01, 2024
GORE® PROPATEN® Vascular Graft
K240083 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 50d
Cleared Mar 01, 2024
Probe Covers (YF-001, YF-002)
K240023 · FLL
Shenzhen YI Fang Blister Packaging...
General Hospital · 58d
Cleared Mar 01, 2024
NUNA LUX (NUNL528)
K233862 · OHS
Premier North America, Inc.
General & Plastic Surgery · 86d
Cleared Mar 01, 2024
LIAISON PLEX Respiratory Flex Assay
K233410 · QOF
Luminex Corporation
Microbiology · 147d
Cleared Mar 01, 2024
S21 OTC Transcutaneous Electrical Nerve Stimulator
K233095 · NUH
Micro Current Technology, Inc.
Neurology · 157d
Cleared Mar 01, 2024
BoneMRI
K233030 · QIH
Mriguidance B.V.
Radiology · 158d
Cleared Mar 01, 2024
IMAGEnet6 Ophthalmic Data System
K232828 · NFJ
Topcon Corporation
Ophthalmic · 170d
Cleared Mar 01, 2024
Access Intact PTH
K232791 · CEW
Beckman Coulter, Inc.
Chemistry · 172d
Cleared Mar 01, 2024
OxiplexTS200
K232385 · MUD
Iss Medical, Inc.
General & Plastic Surgery · 205d
Cleared Mar 01, 2024
Insignis™ Syringe Infusion System
K232328 · FPA
Innovative Health Sciences, LLC
General Hospital · 211d
Cleared Mar 01, 2024
DEKA Infusion System, DEKA Administration Set
K232316 · LDR
Deka Research and Development
General Hospital · 211d
Cleared Mar 01, 2024
Gynatrof
K232040 · NUC
Tyros Biopharma, Inc.
Obstetrics & Gynecology · 235d
Cleared Mar 01, 2024
Zfx Abutments
K231915 · NHA
Zfx GmbH - A Company of Zimvie
Dental · 246d
Cleared Mar 01, 2024
Nihon Kohden NKV-550 Series Ventilator System
K231778 · CBK
Nihon Kohden Orangemed, LLC
Anesthesiology · 259d
Cleared Mar 01, 2024
iCAS-LV
K231690 · QIH
Highrad , Ltd.
Radiology · 266d
Cleared Mar 01, 2024
Muscle Stimulator
K231648 · NUH
Shenzhen Yiran Intelligent Co., Ltd.
Neurology · 270d
Cleared Mar 01, 2024
Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and...
K231365 · LZA
Anhui Intco Medical Products Co., Ltd.
General Hospital · 295d
Cleared Feb 29, 2024
Accu-Joint Hemi Implant
K240268 · KWD
Accufix Surgical, Inc.
Orthopedic · 29d
Cleared Feb 29, 2024
Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit
K240257 · DTK
Bd
Cardiovascular · 29d
Cleared Feb 29, 2024
NPseal (Small, Medium, Large)
K240244 · OKO
Guard Medical, Inc.
General & Plastic Surgery · 30d