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
12577–12600 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 2022
Endoscope Model EG-580UT and Endoscope Model EG-580UR
K221952 · ODG
Fujifilm Corporation
Gastroenterology & Urology · 30d
Cleared Aug 04, 2022
Masimo CARESCAPE SpO2 – Masimo with SpHb
K221953 · DQA
Masimo Corporation
Anesthesiology · 30d
Cleared Aug 03, 2022
Solidence Multipockets
K191131 · FRG
Solidence Surgical Corporation
General Hospital · 1192d
Cleared Aug 03, 2022
ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP...
K212181 · DHB
Phadia AB
Immunology · 386d
Cleared Aug 03, 2022
Root ZX3
K213477 · EKZ
J. Morita USA, Inc.
Dental · 278d
Cleared Aug 03, 2022
Cannulated Screws
K213614 · HWC
Maxxion Medical, LLC
Orthopedic · 261d
Cleared Aug 03, 2022
QScreen
K220139 · GWJ
Path Medical GmbH
Ear, Nose, Throat · 197d
Cleared Aug 03, 2022
Transpara 1.7.2
K221347 · QDQ
Screenpoint Medical B.V.
Radiology · 86d
Cleared Aug 03, 2022
Customize
K221432 · QIH
3D-Side S.A.
Radiology · 78d
Cleared Aug 02, 2022
QOCA Portable ECG Monitoring Device
K210179 · DSH
Quanta Computer, Inc.
Cardiovascular · 557d
Cleared Aug 02, 2022
iStent infinite Trabecular Micro-Bypass System, Model iS3
K220032 · KYF
Glaukos Corporation
Ophthalmic · 209d
Cleared Aug 02, 2022
BruxZir NOW
K220816 · EIH
Prismatik Dentalcraft, Inc.
Dental · 134d
Cleared Aug 01, 2022
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with...
K213929 · LZA
O&M Halyard, Inc.
General Hospital · 228d
Cleared Aug 01, 2022
Disposable Medical Nitrile Examination Gloves
K220237 · LZA
Fujian Jixiang Medical Technology...
General Hospital · 186d
Cleared Aug 01, 2022
Consolidated HC Steam Sterilizer
K220736 · FLE
Consolidated Machine Corp.
General Hospital · 140d
Cleared Aug 01, 2022
IPL hair removal
K221451 · OHT
Shenzhen Lizbella Technology Co.,Ltd
General & Plastic Surgery · 75d
Cleared Aug 01, 2022
X-ray Flat Panel Detectors (CareView 1800 RF)
K221549 · MQB
Careray Digital Medical Technology...
Radiology · 62d
Cleared Aug 01, 2022
Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17
K221616 · MHX
Caf Medical Solutions, Inc.
Cardiovascular · 59d
Cleared Aug 01, 2022
CellFX® System
K221671 · GEI
Pulse Biosciences, Inc.
General & Plastic Surgery · 53d
Cleared Jul 30, 2022
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For...
K221773 · LZA
Onetexx Sdn Bhd
General Hospital · 39d
Cleared Jul 29, 2022
DiviTum TKa
K202852 · QTE
Biovica International AB
Immunology · 669d
Cleared Jul 29, 2022
Tablo Hemodialysis System
K211370 · KDI
Outset Medical, Inc.
Gastroenterology & Urology · 451d
Cleared Jul 29, 2022
Bodyport Cardiac Scale
K211585 · DSB
Bodyport, Inc.
Cardiovascular · 431d
Cleared Jul 29, 2022
Medispine - Spinal Needle, Glospine - Spinal Needle
K212982 · BSP
Global Medikit Limited
Anesthesiology · 315d