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
14665–14688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 2022
Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses
K212631 · HQD
Contamac, Ltd.
Ophthalmic · 210d
Cleared Mar 17, 2022
RELIEF Ureteral Stent Kit
K213444 · FAD
Ureteral Stent Company
Gastroenterology & Urology · 143d
Cleared Mar 17, 2022
OxyMinder
K213948 · CCL
Bio-Med Devices, Inc.
Anesthesiology · 90d
Cleared Mar 16, 2022
IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat...
K210528 · MUU
Millennium Medical Technologies Inc...
General & Plastic Surgery · 386d
Cleared Mar 16, 2022
Healgen Strep A Rapid Test Strip (Throat Swab)
K212623 · GTY
Healgen Scientific, LLC
Microbiology · 210d
Cleared Mar 16, 2022
EchoSK and EchoSGyn modules for EchoS Family devices
K212851 · IYO
Echolight S.P.A
Radiology · 190d
Cleared Mar 16, 2022
iTEAR100 Neurostimulator
K213623 · QKV
Olympic Ophthalmics
Ophthalmic · 120d
Cleared Mar 16, 2022
Customize
K213779 · QIH
3D-Side S.A.
Radiology · 103d
Cleared Mar 16, 2022
Intera Refill Kit
K213823 · PTI
Intera Oncology, Inc.
General Hospital · 98d
Cleared Mar 16, 2022
AccuFit Lateral 2-Hole Plate
K220324 · KWQ
Precision Spine, Inc.
Orthopedic · 41d
Cleared Mar 16, 2022
Fiber Dust PRO
K220426 · GEX
Quanta System Spa
General & Plastic Surgery · 30d
Cleared Mar 16, 2022
K Clear
K220726 · NXC
Kline Europe GmbH
Dental · 2d
Cleared Mar 15, 2022
VITEK MS PRIME
K212461 · QBN
bioMerieux, Inc.
Microbiology · 221d
Cleared Mar 15, 2022
VoqX Electronic Stethoscope
K212709 · DQD
Sanolla , Ltd.
Cardiovascular · 201d
Cleared Mar 15, 2022
Fit Pro Breast Pump
K212955 · HGX
Hygeia II Medical Group, Inc.
Obstetrics & Gynecology · 180d
Cleared Mar 15, 2022
Disposable Nitrile Examination Glove
K213121 · LZA
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 169d
Cleared Mar 15, 2022
CerusEndo Microcatheter (027)
K213314 · QJP
Cerus Endovascular, Inc.
Neurology · 162d
Cleared Mar 15, 2022
Peridot Spinal Interbody System
K213980 · ODP
Gbs Commonwealth Co., Ltd.
Orthopedic · 85d
Cleared Mar 14, 2022
Qitexio
K203738 · FMF
Medex
General Hospital · 447d
Cleared Mar 14, 2022
Arterys MICA
K203744 · QIH
Arterys, Inc.
Radiology · 447d
Cleared Mar 14, 2022
2.4mm Distal Radius System
K211324 · HRS
Auxein Medical Private Limited
Orthopedic · 318d
Cleared Mar 14, 2022
Stasis Gel
K211420 · MVL
Belport Company, Inc., Gingi-Pak
Dental · 311d
Cleared Mar 14, 2022
Yadu Medical Face Mask (Level 1)
K212330 · FXX
Henan Yadu Industrial Co., Ltd.
General Hospital · 230d
Cleared Mar 14, 2022
OPN NC PTCA Dilatation Catheter
K212393 · LOX
Sis Medical AG
Cardiovascular · 224d