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
7369–7392 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 2024
hekaDrill
K233958 · ERL
Zethon, Ltd.
Ear, Nose, Throat · 90d
Cleared Mar 14, 2024
LumiGuide Wire
K233853 · DQK
Philips Medical Systems Nederland B.V.
Cardiovascular · 100d
Cleared Mar 14, 2024
Ortho Guidance Precision Knee Software
K233542 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 132d
Cleared Mar 14, 2024
SpermAlign Sperm Separation Device
K232980 · MQK
Cytoswim, Ltd.
Obstetrics & Gynecology · 175d
Cleared Mar 14, 2024
NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
K232803 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 184d
Cleared Mar 14, 2024
da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with...
K232610 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 199d
Cleared Mar 14, 2024
Myriad SPECTRA Light Source
K232567 · QFX
Nico Corporation
Neurology · 203d
Cleared Mar 14, 2024
Define RF Microneedling System
K232301 · GEI
Aesthetic Management Partners
General & Plastic Surgery · 226d
Cleared Mar 14, 2024
QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments
K231850 · NKG
Globus Medical, Inc.
Orthopedic · 265d
Cleared Mar 14, 2024
CloudPoint FastDesign Chairside
K231529 · PNP
Prismatik Dentalcraft, Inc.
Dental · 293d
Cleared Mar 13, 2024
DEKA Loop
K234055 · QJI
Deka Research and Development
Chemistry · 82d
Cleared Mar 13, 2024
CERAMENT G
K234008 · QRR
Bonesupport AB
Orthopedic · 85d
Cleared Mar 13, 2024
ICEfx Cryoablation System (FPRCH8000-02)
K234002 · GEH
Boston Scientific
Orthopedic · 85d
Cleared Mar 13, 2024
CINA-iPE
K233968 · QAS
Avicenna.Ai
Radiology · 89d
Cleared Mar 13, 2024
DEKA ACE Pump System
K233952 · QFG
Deka Research and Development
Chemistry · 89d
Cleared Mar 13, 2024
ACCORD Cable System
K233949 · JDQ
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Mar 13, 2024
IMMULITE® 2000 BR-MA
K233946 · MOI
Siemens Healthcare Diagnostics...
Immunology · 90d
Cleared Mar 13, 2024
MRCP+ version 2 (MRCP+ v2)
K233930 · LLZ
Perspectum
Radiology · 90d
Cleared Mar 13, 2024
BioPoly Radial Head Implant
K233592 · KWI
BioPoly, LLC
Orthopedic · 126d
Cleared Mar 13, 2024
Edison System
K233466 · QGM
HistoSonics, Inc.
General & Plastic Surgery · 141d
Cleared Mar 13, 2024
Hygeia Express Powered Breast Pump
K233136 · HGX
Hygeia II Medical Group, Inc.
Obstetrics & Gynecology · 168d
Cleared Mar 13, 2024
Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)
K233070 · NGX
Chongqing Rob Linka Science and...
Physical Medicine · 169d
Cleared Mar 13, 2024
CAS-One IR
K232022 · JAK
Cascination AG
Radiology · 250d
Cleared Mar 12, 2024
Smartxide Tetra Pro
K240497 · GEX
El.En S.P.A.
General & Plastic Surgery · 21d