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
6313–6336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 2024
BriefCase-Triage
K241727 · QAS
Aidoc Medical , Ltd.
Radiology · 28d
Cleared Jul 12, 2024
VersaCross Connect™ Transseptal Dilator
K241720 · DRE
Baylis Medical Company, Inc.
Cardiovascular · 28d
Cleared Jul 12, 2024
Dental Glass Ceramics Blocks (HT,LT,ST)
K241715 · EIH
Aidite (Qinhuangdao) Technology Co.,...
Dental · 28d
Cleared Jul 12, 2024
HiRise (1040-230)
K241713 · JAK
Curvebeam, LLC
Radiology · 28d
Cleared Jul 12, 2024
OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™
K241707 · LPL
Unicon Optical Co., Ltd.
Ophthalmic · 29d
Cleared Jul 12, 2024
MilkMate Breast Pump (A0006)
K241705 · HGX
Milkmate Products, Inc.
Obstetrics & Gynecology · 29d
Cleared Jul 12, 2024
Endoscopic Video Image Processor (RP-IPD-V2000EF)
K241500 · FAJ
Guangzhou Red Pine Medical Instrument...
Gastroenterology & Urology · 45d
Cleared Jul 12, 2024
S.I.N. Instrument Kits
K241378 · KCT
S.I.N. ? Sistema DE Implante Nacional...
General Hospital · 58d
Cleared Jul 12, 2024
Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN...
K241085 · GEI
Covidien, LLC
General & Plastic Surgery · 84d
Cleared Jul 12, 2024
TMINI Miniature Robotic System (TMINI 1.1)
K241031 · OLO
THINK Surgical, Inc.
Orthopedic · 88d
Cleared Jul 12, 2024
KLS Martin Orthopedic Implants - MR Conditional
K241018 · HRS
KLS-Martin L.P.
Orthopedic · 88d
Cleared Jul 12, 2024
HemoCare Bicarbonate Concentrate Set (BCS)
K240920 · KPO
Deka Research and Development
Gastroenterology & Urology · 99d
Cleared Jul 12, 2024
Geistlich Bio-Oss®
K240661 · NPM
Geistlich Pharma AG
Dental · 126d
Cleared Jul 12, 2024
MRI Universal
K240651 · JEY
Stryker Leibinger GmbH & Co KG
Dental · 127d
Cleared Jul 12, 2024
“MoFi” Cell Culture Basal Medium
K240247 · NDS
Duogenic Stemcells Corporation
Gastroenterology & Urology · 164d
Cleared Jul 12, 2024
Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®,...
K240240 · NHA
Prismatik Dentalcraft, Inc.
Dental · 164d
Cleared Jul 12, 2024
Single Use Hemoclips
K234124 · PKL
Promisemed Hangzhou Meditech Co., Ltd.
Gastroenterology & Urology · 197d
Cleared Jul 12, 2024
SPIRA® Anterior Lumbar Spacers
K234077 · MAX
Camber Spine Technologies
Orthopedic · 203d
Cleared Jul 12, 2024
Acorn 3D Software (AC-SEG-4009)
K234009 · QIH
Mighty Oak Medical
Radiology · 206d
Cleared Jul 12, 2024
Infinity Gateway Suite
K233834 · MSX
Draeger Medical Systems, Inc.
Cardiovascular · 221d
Cleared Jul 12, 2024
Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne...
K233644 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 242d
Cleared Jul 12, 2024
HemoCare Hemodialysis System
K233557 · KDI
Deka Research and Development
Gastroenterology & Urology · 249d
Cleared Jul 12, 2024
RUS
K233457 · QIH
Hutom, Inc.
Radiology · 266d
Cleared Jul 12, 2024
Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)
K232372 · GAM
Peters Surgical
General & Plastic Surgery · 339d