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
24985–25008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 2018
Octane Mechanical Thrombectomy System
K182232 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 25d
Cleared Sep 10, 2018
IntelliSpace Perinatal Rev.K.00
K173941 · HGM
Philips Medizin Systeme Boeblingen GmbH
Obstetrics & Gynecology · 258d
Cleared Sep 10, 2018
The Sex Gel
K181078 · NUC
Necessaire, Inc.
Obstetrics & Gynecology · 139d
Cleared Sep 10, 2018
Human Tecar HCR 1002
K181211 · PBX
Unibell S.R.L
General & Plastic Surgery · 126d
Cleared Sep 10, 2018
XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0
K181415 · OWB
Canon Medical Systems Corporation
Radiology · 103d
Cleared Sep 10, 2018
ProSun sunlamp products, Luxura sunlamp products
K181455 · LEJ
Prosun International, LLC
General & Plastic Surgery · 98d
Cleared Sep 10, 2018
SECULOK™ ACP System
K182055 · KWQ
U&I Corporation
Orthopedic · 41d
Cleared Sep 07, 2018
mediCAD 4.0
K170702 · LLZ
Medicad Hectec GmbH
Radiology · 548d
Cleared Sep 07, 2018
IPL Hair Removal Device Joy Version
K173813 · OHT
Shen Zhen Cosbeauty Co., Ltd.
General & Plastic Surgery · 266d
Cleared Sep 07, 2018
External Fixation System
K173883 · KTT
Life Spine, Inc.
Orthopedic · 260d
Cleared Sep 07, 2018
Exceed Microneedling Device
K180778 · QAI
Mt. Derm GmbH
General & Plastic Surgery · 165d
Cleared Sep 07, 2018
Corin Optimized Positioning System (OPS) Femoral
K181061 · LZO
Corin USA
Orthopedic · 137d
Cleared Sep 07, 2018
Disposable SpO2 Sensors, Reusable SpO2 Sensors
K181270 · DQA
Orantech, Inc.
Anesthesiology · 116d
Cleared Sep 07, 2018
Philips Hemodynamic Application R1.0
K181311 · MWI
Philips Medical Systems Nederlands B.V.
Cardiovascular · 113d
Cleared Sep 07, 2018
AMSure Sterile Water, and Sterile Normal Saline for Wound Flush
K181423 · FRO
Amsino International, Inc.
General & Plastic Surgery · 99d
Cleared Sep 07, 2018
INNOVANCE Free PS Ag
K181525 · GGP
Siemens Healthcare Diagnostics...
Hematology · 88d
Cleared Sep 07, 2018
GLOW800
K181537 · IZI
Leica Microsystems (Schweiz) AG
Neurology · 88d
Cleared Sep 07, 2018
R-C1 TENS and EMS Stimulator
K181688 · IPF
Shenzhen Roundwhale Technology Co. ,...
Physical Medicine · 73d
Cleared Sep 07, 2018
ReTrace Ureteral Access Sheath
K181811 · FED
Coloplast A/S
Gastroenterology & Urology · 63d
Cleared Sep 07, 2018
Ultravision™ Visual Field Clearing System
K182053 · PQM
Alesi Surgical, Ltd.
General Hospital · 38d
Cleared Sep 07, 2018
Solstice SRS Immobilization System
K182079 · IYE
Medtec Inc. Dba Civco Medical Solutions
Radiology · 36d
Cleared Sep 07, 2018
Bi-Flex Evo
K182144 · KNY
Promepla Sam
Gastroenterology & Urology · 30d
Cleared Sep 07, 2018
CTXX85
K182147 · JAK
Analogic Corporation
Radiology · 30d
Cleared Sep 07, 2018
SILVERBACK Gorilla Plating System
K182148 · HWC
Paragon 28, Inc.
Orthopedic · 30d