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
24865–24888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 2018
Stat Profile Prime Plus Analyzer System
K180340 · CGA
Nova Biomedical Corporation
Chemistry · 231d
Cleared Sep 26, 2018
BeautiBond Universal
K180803 · KLE
Shofu Dental Corporation
Dental · 182d
Cleared Sep 26, 2018
Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and...
K181066 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 156d
Cleared Sep 26, 2018
The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex...
K181563 · DQY
Access Scientific, LLC
Cardiovascular · 104d
Cleared Sep 26, 2018
Fixated Asfora BULLET CAGE® (FABC)
K181591 · MAX
Medical Designs, LLC
Orthopedic · 100d
Cleared Sep 26, 2018
Everyway Wireless TENS & EMS Unit
K181707 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 90d
Cleared Sep 26, 2018
NxStage Connected Health System
K181991 · FKP
Nxstage Medical, Inc.
Gastroenterology & Urology · 62d
Cleared Sep 26, 2018
Magic Torque DLVR Guidewire
K182315 · DQX
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Sep 26, 2018
InMode RF System
K182325 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 30d
Cleared Sep 26, 2018
HardyDisk AST Eravacycline 20µg (ERV20)
K182357 · JTN
Hardy Diagnostics
Microbiology · 27d
Cleared Sep 25, 2018
skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1...
K173127 · LCP
Skyla Corporation H.S.P.B
Chemistry · 361d
Cleared Sep 25, 2018
PeDIA
K181424 · BTC
Pedia, LLC
Anesthesiology · 117d
Cleared Sep 25, 2018
5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag...
K181692 · NEU
Health Beacons, Inc.
General & Plastic Surgery · 90d
Cleared Sep 25, 2018
Synapse 3D Optional Tools
K181773 · LLZ
Fujifilm Corporation
Radiology · 84d
Cleared Sep 25, 2018
AST Model MA012 and MS019 Rehab Wheelchair
K181795 · IOR
Sichuan Ast Medical Equipment Co., Ltd.
Physical Medicine · 82d
Cleared Sep 25, 2018
5 FR Dual Lumen Piper PICC
K181904 · LJS
Piper Access, LLC
General Hospital · 71d
Cleared Sep 25, 2018
OsseoScrew System
K181980 · NKB
Alphatec Spine, Inc.
Orthopedic · 62d
Cleared Sep 25, 2018
IBM iConnect Access
K182290 · LLZ
Merge Healthcare Incorporated
Radiology · 33d
Cleared Sep 25, 2018
CPX 4 Breast Tissue Expander with Smooth Surface
K182335 · LCJ
Mentor Worldwide, LLC
General & Plastic Surgery · 28d
Cleared Sep 24, 2018
Probe Covers for Thermometers
K180714 · FLL
K-Jump Health Co., Ltd.
General Hospital · 189d
Cleared Sep 24, 2018
iNtuition-T1 Mapping and T2/T2* Mapping
K180916 · LLZ
Terarecon,Inc.
Radiology · 168d
Cleared Sep 24, 2018
REDAPT Porous Acetabular Shell
K181366 · LPH
Smith & Nephew, Inc.
Orthopedic · 124d
Cleared Sep 24, 2018
Comprehensive Reverse Shoulder System
K181611 · PHX
Biomet Manufacturing Corp
Orthopedic · 97d
Cleared Sep 24, 2018
AMADEO M-DR mini, AMADEO M-AX mini
K182317 · IZL
Oehm Und Rehbein GmbH
Radiology · 28d