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
15817–15840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 2021
TaiChiB
K210921 · IYE
Our United Corporation
Radiology · 218d
Cleared Nov 02, 2021
Tapestry Biointegrative Implant
K212306 · OWY
Embody, Inc.
Orthopedic · 102d
Cleared Nov 02, 2021
VisionX 3.0
K213326 · LLZ
Durr Dental SE
Radiology · 28d
Cleared Nov 01, 2021
Alpha Dent Implants Dental Implants System
K210499 · DZE
Alpha Dent Implants GmbH
Dental · 252d
Cleared Nov 01, 2021
BioFire COVID-19 Test 2
K211079 · QQX
Biofire Defense, LLC
Microbiology · 203d
Cleared Nov 01, 2021
Nitrile Examination Gloves (Blue, Violet)
K211586 · LZA
Lyncmed Medical Technology (Beijing)...
General Hospital · 161d
Cleared Nov 01, 2021
Electronic Blood Pressure Monitor
K212171 · DXN
Dongguan Kangweile Electronic...
Cardiovascular · 112d
Cleared Nov 01, 2021
SterileRight sterilization pouch and roll
K212338 · FRG
Sterileright Packaging Mfg., Inc.
General Hospital · 97d
Cleared Nov 01, 2021
DePuy CONDUIT LLIF Angled Inserters
K212823 · MAX
Enztec Limited
Orthopedic · 59d
Cleared Nov 01, 2021
Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA,...
K212948 · NGX
Guangzhou Xinbo Electronic Co., Ltd.
Physical Medicine · 46d
Cleared Oct 31, 2021
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K210588 · LZA
Onetexx Sdn Bhd
General Hospital · 247d
Cleared Oct 30, 2021
Tracheal Stent System (Y-Shaped)
K212403 · JCT
Micro-Tech (Nanjing) Co., Ltd.
Anesthesiology · 89d
Cleared Oct 29, 2021
Phoenix Digital Thermometer
K201032 · FLL
Phoenix Innovative Healthcare...
General Hospital · 557d
Cleared Oct 29, 2021
N Latex FLC kappa, N Latex FLC lambda
K201496 · DFH
Siemens Healthcare Diagnostics...
Immunology · 511d
Cleared Oct 29, 2021
Enbio S
K210279 · FLE
Enbio Group AG
General Hospital · 270d
Cleared Oct 29, 2021
TraumaGuard Intra-abdominal Pressure Sensing System
K210570 · PHU
Sentinel Medical Technologies, LLC
General & Plastic Surgery · 245d
Cleared Oct 29, 2021
nView s1 with nav option
K211064 · OWB
Nview Medical
Radiology · 203d
Cleared Oct 29, 2021
Critical Care Suite with Endotracheal Tube Positing AI algorithm
K211161 · QIH
Ge Medical Systems, LLC
Radiology · 193d
Cleared Oct 29, 2021
ATEC Alignment App
K211987 · LLZ
Alphatec Spine, Inc.
Radiology · 123d
Cleared Oct 29, 2021
SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue...
K212308 · LZA
Srirungruang Global Co., Ltd.
General Hospital · 98d
Cleared Oct 29, 2021
Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF
K212389 · MAX
Intelivation, LLC
Orthopedic · 88d
Cleared Oct 29, 2021
MectaLIF Extension
K212831 · MAX
Medacta International S.A.
Orthopedic · 52d
Cleared Oct 29, 2021
VersaWrap
K213163 · FTM
Alafair Biosciences, Inc.
General & Plastic Surgery · 31d
Cleared Oct 29, 2021
Balloon BS-3
K213195 · FDA
Fujifilm Corporation
Gastroenterology & Urology · 30d