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
22129–22152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 2019
PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
K183516 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 262d
Cleared Sep 06, 2019
EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F
K183525 · PSV
Olympus Medical Systems Corp.
Ear, Nose, Throat · 261d
Cleared Sep 06, 2019
SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes
K183574 · DPW
Huntleigh Healthcare , Ltd.
Cardiovascular · 259d
Cleared Sep 06, 2019
Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile...
K183665 · MEG
Jiangsu Micsafe Medical Technology...
General Hospital · 253d
Cleared Sep 06, 2019
Yikang Endotracheal Tube
K190213 · BTR
Jiangxi Yikang Medical Instrument...
Anesthesiology · 214d
Cleared Sep 06, 2019
Microscope Navigation
K190250 · HAW
Brainlab AG
Neurology · 211d
Cleared Sep 06, 2019
Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With...
K190403 · LZA
Ever Global (Vietnam) Enterprise...
General Hospital · 199d
Cleared Sep 06, 2019
Gem FlowCoupler System
K190499 · MVR
Baxter/ Synovis Micro Companies...
General & Plastic Surgery · 189d
Cleared Sep 06, 2019
Precision S 4K Sinuscope
K191102 · EOB
Stryker
Ear, Nose, Throat · 134d
Cleared Sep 06, 2019
Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc...
K191121 · LPL
Lentechs, LLC
Ophthalmic · 133d
Cleared Sep 06, 2019
Transvaginal Access Platform
K191294 · HEW
Applied Medical Resources Corp.
Obstetrics & Gynecology · 115d
Cleared Sep 06, 2019
Vacutore Air/Water Bottle Tubing
K191366 · OCX
Smartdata Suzhou Co., Ltd.
Gastroenterology & Urology · 107d
Cleared Sep 06, 2019
AcQMap High Resolution Imaging and Mapping System
K191392 · DQK
Acutus Medical, Inc.
Cardiovascular · 105d
Cleared Sep 06, 2019
IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40...
K191435 · GZF
Nalu Medical, Inc.
Neurology · 99d
Cleared Sep 06, 2019
Venus Legacy Pro Device
K191528 · GEI
Venus Concept USA, Inc.
General & Plastic Surgery · 88d
Cleared Sep 06, 2019
Sure-Fine Insulin Syringes
K191531 · FMF
Shina Med Corporation
General Hospital · 88d
Cleared Sep 06, 2019
Willow Wearable Breast Pump 2.0
K191577 · HGX
Exploramed Nc7, Inc.
Obstetrics & Gynecology · 84d
Cleared Sep 06, 2019
TTC Phantom Intramedullary Nail System
K191782 · HSB
Paragon 28, Inc.
Orthopedic · 66d
Cleared Sep 06, 2019
Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive...
K191845 · PGY
Barco N.V.
Radiology · 58d
Cleared Sep 06, 2019
EVO Platform
K192160 · GEX
Quanta System Spa
General & Plastic Surgery · 28d
Cleared Sep 06, 2019
Aquilion ONE (TSX-306A/3) V10.0
K192188 · JAK
Canon Medical Systems Corporation
Radiology · 24d
Cleared Sep 06, 2019
Lumify Diagnostic Ultrasound System
K192226 · IYN
Philips Health Care
Radiology · 21d
Cleared Sep 05, 2019
EVIS EXERA III Bronchovideoscope Olympus BF-XT190
K183419 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 269d
Cleared Sep 05, 2019
FUJIFILM Ultrasonic Endoscope
K183433 · ODG
Fujifilm Corporation
Gastroenterology & Urology · 268d