FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
6577–6600 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 2024
Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible...
K233778 · FGB
Zhuhai Pusen Medical Technology Co.,...
Gastroenterology & Urology · 232d
Cleared Jul 15, 2024
NeuroLF (Basic)
K241751 · KPS
Positrigo AG
Radiology · 27d
Cleared Jul 15, 2024
Endoscopic Applicator, 41 cm
K241739 · GCJ
Micromedics, Inc.
General & Plastic Surgery · 28d
Cleared Jul 15, 2024
BellaTek Bars
K241032 · NHA
Biomet 3i, LLC
Dental · 90d
Cleared Jul 15, 2024
FAQ™ (102)
K240616 · PAY
Foreo, Inc.
Physical Medicine · 132d
Cleared Jul 15, 2024
Huxley SANSA Home Sleep Apnea Test (1000-00)
K240285 · MNR
Huxley Medical
Anesthesiology · 165d
Cleared Jul 15, 2024
RFG-01
K240178 · PBX
Zimmer Medizinsysteme GmbH
General & Plastic Surgery · 174d
Cleared Jul 15, 2024
CM00622 LINC Skin Closure System (CM00622 LINC)
K233460 · OMD
Connexicon Medical , Ltd.
General & Plastic Surgery · 266d
Cleared Jul 15, 2024
CM005 Standard (CM005)
K233458 · MPN
Connexicon Medical , Ltd.
General & Plastic Surgery · 266d
Cleared Jul 15, 2024
Avantik VTM
K233449 · JSM
Hanchang Medic Co., Ltd. (Han Chang...
Microbiology · 269d
Cleared Jul 13, 2024
Omnifix Syringe NRFit
K241385 · QEH
B.Braun Medical, Inc.
General Hospital · 59d
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