FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

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

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175,820 results
26857–26880 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 2018
Rusch Intermittent Urethral Catheters
K173596 · EZC
Teleflex Medical
Gastroenterology & Urology · 69d
Cleared Jan 29, 2018
DeGen Medical E3 MIS Pedicle Screw System
K173814 · NKB
Degen Medical
Orthopedic · 45d
Cleared Jan 26, 2018
MiCor A100 Wearable ECG Recorder
K162665 · DPS
Mitac International Corp.
Cardiovascular · 487d
Cleared Jan 26, 2018
SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE...
K171367 · LYY
Sanrea Healthcare Products Pvt, Ltd.
General Hospital · 262d
Cleared Jan 26, 2018
Stryker 90-S Max SERFAS Energy Probe
K171391 · GEI
Stryker
General & Plastic Surgery · 260d
Cleared Jan 26, 2018
V2K Rinspiration System
K172716 · QEW
V2k Medical, Inc.
Cardiovascular · 140d
Cleared Jan 26, 2018
TiGer Shark™ System
K172816 · MAX
Choicespine, LP
Orthopedic · 130d
Cleared CT Jan 26, 2018
SedLine Sedation Monitor
K172890 · OLW
Masimo Corporation
Neurology · 126d
Cleared Jan 26, 2018
Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A,...
K172896 · DXN
Shenzhen Jiacom Technology CO ., Ltd.
Cardiovascular · 126d
Cleared Jan 26, 2018
Embrace
K172935 · POS
Empatica S.R.L.
Neurology · 122d
Cleared Jan 26, 2018
Essence 55S Large Monitor System
K172969 · DXJ
Shenyang Torch-Bigtide Digital...
Cardiovascular · 122d
Cleared Jan 26, 2018
DRAGON X SPSL4HC, DRAGON X SPSL8HC
K173299 · IZL
Sedecal., Sa.
Radiology · 101d
Cleared Jan 26, 2018
Vantage Galan 3T, V4.6
K173382 · LNH
Toshibamedical Systems Corporation
Radiology · 88d
Cleared Jan 26, 2018
SeQure® NF and SeQure® Microcatheters
K173430 · DQO
Accurate Medical Therapeutics, Ltd.
Cardiovascular · 85d
Cleared Jan 26, 2018
Panthera Dental Milled Bars
K173466 · NHA
Panthera Dental, Inc.
Dental · 79d
Cleared Jan 26, 2018
SyMRI
K173558 · LNH
Syntheticmr AB
Radiology · 70d
Cleared Jan 26, 2018
Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
K173709 · DQY
Inneuroco, Inc.
Cardiovascular · 53d
Cleared Jan 26, 2018
illumiflow 148 Laser Cap
K173843 · OAP
Eglobal, LLC
General & Plastic Surgery · 39d
Cleared Jan 26, 2018
Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
K173932 · OCC
Alere Scarborough, Inc.
Microbiology · 31d
Cleared Jan 26, 2018
uDR 780i
K173953 · KPR
Shanghai United Imaging Healthcare...
Radiology · 30d
Cleared Jan 26, 2018
Mic-Key* SF Over-the-Wire Stoma Measuring Device
K173955 · KNT
Halyard Health, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 25, 2018
Royal Flush Catheter
K171264 · DQO
Cook Incorporated
Cardiovascular · 269d
Cleared Jan 25, 2018
ClearLine IV
K171954 · OKL
Clearline MD
General Hospital · 210d
Cleared Jan 25, 2018
EchoGlo Needle
K171968 · BSP
Smiths Medical Asd, Inc.
Anesthesiology · 209d