Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
36769–36792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Oct 29, 2014
EpiAccess System
K142245 · DYB
Epiep, Inc.
Cardiovascular · 77d
Cleared Oct 29, 2014
cryoICE croablation probe
K142441 · GEH
AtriCure, Inc.
General & Plastic Surgery · 57d
Cleared Oct 29, 2014
IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free...
K142811 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Oct 29, 2014
ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur...
K142864 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 28d
Cleared Oct 29, 2014
Leo Minor
K142984 · FSY
Sunnex, Inc.
General & Plastic Surgery · 13d
Cleared Oct 28, 2014
KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTS
K132771 · GEI
Qingdao Kingston Medical Devices, Ltd.
General & Plastic Surgery · 418d
Cleared CT Oct 28, 2014
HYPERQ ACS-100 SYSTEM
K140020 · DPS
Bsp-Biiological Signal Processing, Ltd.
Cardiovascular · 298d
Cleared Oct 28, 2014
ALLOX2 TISSUE EXPANDERS
K140383 · LCJ
Specialty Surgical Products, Inc.
General & Plastic Surgery · 256d
Cleared Oct 28, 2014
LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE...
K141221 · EFB
Lares Research, Inc.
Dental · 169d
Cleared Oct 28, 2014
APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0
K141459 · IYN
Toshibamedical Systems Corporation
Radiology · 148d
Cleared Oct 28, 2014
EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING...
K141686 · DWJ
Smith Medical Asd, Inc.
Cardiovascular · 127d
Cleared Oct 28, 2014
SMARTGRAFT 200 SYSTEM
K141713 · MUU
Ingeneron, Inc.
General & Plastic Surgery · 125d
Cleared Oct 28, 2014
#8C RENEGADE DENTAL HANDPIECE
K142063 · EFB
Handpiece Club, LLC
Dental · 90d
Cleared Oct 28, 2014
ZIMMER 3.1MM DENTAL IMPLANT
K142082 · DZE
Zimmer Dental, Inc.
Dental · 89d
Cleared Oct 28, 2014
EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
K142084 · OCL
Ncontact Surgical, Inc.
Cardiovascular · 89d
Cleared Oct 28, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP
K142170 · LON
Becton, Dickinson and Company
Microbiology · 82d
Cleared Oct 28, 2014
Well Lead PVC Urethral Catheter
K142563 · EZD
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 47d
Cleared Oct 28, 2014
Fortrex 0.035 OTW PTA Balloon Catheter
K142654 · LIT
Covidien, LLC
Cardiovascular · 40d
Cleared Oct 28, 2014
E-CUBE 5
K142733 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 35d
Cleared Oct 28, 2014
E-CUBE 12
K142884 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 26d
Cleared Oct 28, 2014
Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh),...
K142900 · FTL
Sofradim Production
General & Plastic Surgery · 22d
Cleared Oct 27, 2014
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA...
K140225 · MOB
Phadia US, Inc.
Immunology · 271d
Cleared Oct 27, 2014
PROCESS INDICATOR TAPE FOR STEAM STERILIZATION
K140940 · JOJ
Canadian Technical Tape, Ltd.
General Hospital · 196d
Cleared Oct 27, 2014
BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)
K141331 · JDI
Biomet, Inc.
Orthopedic · 159d