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
22441–22464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 2019
Atellica CH Amylase_2 (AMY_2)
K191454 · JFJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 60d
Cleared Jul 30, 2019
Renuvion/J-Plasma Precise Handpiece
K191484 · GEI
Apyx Medical Corporation(Formerly...
General & Plastic Surgery · 56d
Cleared Jul 30, 2019
AXS Vecta Aspiration System
K191768 · NRY
Stryker Neurovascular
Neurology · 29d
Cleared Jul 29, 2019
Quantisal II Oral Fluid Collection Device
K183048 · PJD
Immunalysis Corporation
Chemistry · 269d
Cleared Jul 29, 2019
Helioseal F Plus
K190339 · EBC
Ivoclar Vivadent, AG
Dental · 165d
Cleared Jul 29, 2019
Shaders ZR
K190569 · EIH
Digital Age Dental Lab
Dental · 145d
Cleared Jul 29, 2019
Sample Imaging for Senographe Pristina
K190809 · MUE
Ge Healthcare
Radiology · 122d
Cleared Jul 29, 2019
Non-invasive blood pressure measurement systems
K190886 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 116d
Cleared Jul 29, 2019
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
K190907 · LSR
Zeus Scientific, Inc.
Microbiology · 112d
Cleared Jul 29, 2019
Access CT
K191136 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 91d
Cleared Jul 29, 2019
Hair Boom 69
K191154 · OAP
Wontech
General & Plastic Surgery · 89d
Cleared Jul 29, 2019
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
K191240 · LSR
Zeus Scientific, Inc.
Microbiology · 82d
Cleared Jul 29, 2019
Bone Screw Line Addition
K191289 · HWC
Vilex IN Tennessee, Inc.
Orthopedic · 77d
Cleared Jul 29, 2019
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
K191398 · LSR
Zeus Scientific, Inc.
Microbiology · 66d
Cleared Jul 29, 2019
CoLink® Mini Plating System
K191535 · HRS
In2bones USA, LLC
Orthopedic · 49d
Cleared Jul 29, 2019
BiomarC Fiducial Marker
K191797 · IYE
Carbon Medical Technologies
General & Plastic Surgery · 26d
Cleared Jul 28, 2019
Bonus Therapeutics Mixing and Delivery System
K190996 · FMF
Bonus Therapeutics , Ltd.
Orthopedic · 103d
Cleared Jul 26, 2019
ACR LAB Urine Analysis Test System
K182384 · JFY
Healthy.Io, Ltd.
Chemistry · 329d
Cleared Jul 26, 2019
KLS Martin Individual Patient Solutions (IPS) Planning System
K182889 · PPT
KLS-Martin L.P.
Neurology · 284d
Cleared Jul 26, 2019
Medtronic Total Hip Arthroplasty System
K183129 · LPH
Medtronic Advanced Energy
Orthopedic · 255d
Cleared CT Jul 26, 2019
Arthrex Eclipse Shoulder Prosthesis System
K183194 · QHQ
Arthrex, Inc.
Orthopedic · 249d
Cleared Jul 26, 2019
AI-Rad Companion (Pulmonary)
K183271 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 245d
Cleared Jul 26, 2019
PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested...
K183280 · LZA
Smart Glove Corporation Sdn. Bhd.
General Hospital · 245d
Cleared Jul 26, 2019
RapidVit™ Oocyte, RapidWarm™ Oocyte
K183486 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 221d