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
35857–35880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 2014
RADAR VASCULAR COMPRESSION DEVICE
K142122 · DXC
Advanced Vascular Dynamics
Cardiovascular · 122d
Cleared Dec 04, 2014
NATURE'S BOND 600 AND NATURE'S BOND 603
K142168 · HGX
Devon Medical Products, Inc.
Obstetrics & Gynecology · 120d
Cleared Dec 04, 2014
ActiveCare+SFT
K142728 · JOW
Medical Compressions System (Dbn) , Ltd.
Cardiovascular · 72d
Cleared Dec 04, 2014
Endovascular Stent Planning Software
K143079 · LLZ
Vital Images, Inc.
Radiology · 38d
Cleared Dec 04, 2014
SafeAir Smoke Pencil
K143145 · GEI
Lina Medical Aps
General & Plastic Surgery · 31d
Cleared Dec 03, 2014
CLEARVIEW
K133373 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 397d
Cleared Dec 03, 2014
X TWIN SYSTEM
K133496 · KPR
Roesys GmbH
Radiology · 384d
Cleared Dec 03, 2014
5000Z FIREFLY SYSTEM
K133502 · NUH
Prizm Medical, Inc.
Neurology · 384d
Cleared Dec 03, 2014
ENDOLUMINAL OCCLUSION SYSTEM (EOS)
K133924 · KRD
Artventive Medical Group, Inc.
Cardiovascular · 345d
Cleared Dec 03, 2014
STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR
K140589 · FRC
Mesa Laboratories, Inc.
General Hospital · 271d
Cleared Dec 03, 2014
SYNGO.CT COLONOGRAPHY
K140920 · NWE
Siemens Medical Solutions USA, Inc.
Radiology · 237d
Cleared Dec 03, 2014
INMODE WMFACE DEVICE
K140926 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 236d
Cleared Dec 03, 2014
SURVEYOR S4 MOBILE MONITOR
K141020 · DRG
Mortara Instrument, Inc.
Cardiovascular · 226d
Cleared Dec 03, 2014
WANGHUI NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
K141279 · LZA
Wanghui Glove Co., Ltd.
General Hospital · 201d
Cleared Dec 03, 2014
HUIKANG NITRILE POWDER FREE PATIENT EXAM GLOVES, BLUE COLOR
K141287 · LZA
Huikang Glove Co., Ltd.
General Hospital · 201d
Cleared Dec 03, 2014
STERILUCENT SELF-SEAL STERILIZATION POUCH
K141412 · FRG
Gs Medical Packaging, Inc.
General Hospital · 188d
Cleared Dec 03, 2014
ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER
K141529 · DQY
Alvimedica Tibbi Urunler Sanayi VE...
Cardiovascular · 177d
Cleared Dec 03, 2014
MAXPOWER RELIEF
K141978 · NUH
Omron Healthcare, Inc.
Neurology · 135d
Cleared Dec 03, 2014
MAC 800 Resting ECG Analysis System
K142288 · DPS
Ge Medical Systems China Co., Ltd.
Cardiovascular · 107d
Cleared Dec 03, 2014
AliveCor Heart Monitor
K142672 · DXH
AliveCor, Inc.
Cardiovascular · 75d
Cleared Dec 03, 2014
ZOLL X Series
K142915 · MKJ
ZOLL Medical Corporation
Cardiovascular · 57d
Cleared Dec 03, 2014
M3290B Philips IntelliVue Information Center iX
K143057 · MSX
Philips Medical Systems
Cardiovascular · 40d
Cleared Dec 03, 2014
ST AIA-PACK PROG II Calibrator Set
K143144 · JIT
Tosoh Bioscience, Inc.
Chemistry · 30d
Cleared Dec 03, 2014
12 mm & Stapler Bladeless Obturators
K143217 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 23d