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
7705–7728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 2024
MightySat -OTC
K214115 · OLK
Masimo Corporation
Anesthesiology · 762d
Cleared Jan 30, 2024
Ziehm Vision FD
K240020 · OWB
Ziehm Imaging GmbH
Radiology · 28d
Cleared Jan 30, 2024
VIVA combo RF System (VIVA combo RF System)
K234140 · GEI
Starmed Co., Ltd.
General & Plastic Surgery · 32d
Cleared Jan 30, 2024
VariTrax Sternal CircumFixation System
K232986 · JDQ
Circumfix Solutions, Inc.
Orthopedic · 130d
Cleared Jan 30, 2024
G-Vitri™ Vitrification Freeze Media
K232942 · MQL
Gimbo Medical Technology Shenzhen...
Obstetrics & Gynecology · 132d
Cleared Jan 30, 2024
E3D™-A Interbody System
K232432 · OVD
Evolution Spine
Orthopedic · 172d
Cleared Jan 30, 2024
DermRays Revive
K231910 · GEX
Wuhan Lotuxs Technology Co., Ltd.
General & Plastic Surgery · 215d
Cleared Jan 30, 2024
Redemption Duo Hindfoot Nail System
K231343 · HSB
Vilex, LLC
Orthopedic · 266d
Cleared Jan 29, 2024
Rebuilder Nerve Guidance Conduit
K230794 · JXI
Celestray Biotech Company, LLC.,
Neurology · 313d
Cleared Jan 28, 2024
Gem Flow Now (GEM2770-FN)
K233394 · IYN
Synovis Micro Companies Alliance
Cardiovascular · 117d
Cleared Jan 27, 2024
Epilaser Pro
K233224 · GEX
Epilady 2000, LLC
General & Plastic Surgery · 121d
Cleared Jan 26, 2024
ViSiGi 3D Gastric Sizing Tube
K234145 · KNT
Boehringer Laboratories
Gastroenterology & Urology · 28d
Cleared Jan 26, 2024
CentriMag™ Acute Circulatory Support System
K234118 · QNR
Abbott Medical
Cardiovascular · 29d
Cleared Jan 26, 2024
Trigon Trigon HA Stand-Alone Wedge Fixation System
K234116 · PLF
Nvision Biomedical Technologies
Orthopedic · 30d
Cleared Jan 26, 2024
Ziehm Solo FD
K234109 · OWB
Ziehm Imaging GmbH
Radiology · 30d
Cleared Jan 26, 2024
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested...
K233598 · LZA
Anhui Intco Medical Products Co., Ltd.
General Hospital · 78d
Cleared Jan 26, 2024
iFuse Bedrock Granite® Implant System
K233508 · OUR
SI-BONE, Inc.
Orthopedic · 87d
Cleared Jan 26, 2024
M-Wave
K233485 · IPF
Zynex Medical, Inc.
Physical Medicine · 91d
Cleared Jan 26, 2024
ExactechGPS® System
K233299 · OLO
Blue Ortho
Orthopedic · 119d
Cleared Jan 26, 2024
EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
K232864 · LCX
Nantong Egens Biotechnology Co., Ltd.
Chemistry · 133d
Cleared Jan 26, 2024
Disposable Hemostatic Clips
K232450 · PKL
Zhejiang Soudon Medical Technology...
Gastroenterology & Urology · 165d
Cleared Jan 26, 2024
One-Fil
K232182 · KIF
Mediclus Co., Ltd.
Dental · 186d
Cleared Jan 26, 2024
Perifit Pump
K231785 · HGX
X6 Innovations
Obstetrics & Gynecology · 220d
Cleared Jan 26, 2024
MONDRIAN™ Anterior Lumbar Plate System
K231715 · KWQ
Ctl Medical Corporation
Orthopedic · 227d