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
26209–26232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 2018
HEALIX ADVANCE Anchor with DYNACORD Suture
K173859 · MAI
Medos International SARL
Orthopedic · 112d
Cleared Apr 11, 2018
s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular...
K173860 · IYO
Volcano Corporation
Radiology · 112d
Cleared Apr 11, 2018
Corin TriFit CF Hip Stem
K173880 · MEH
Corin U.S.A. Limited
Orthopedic · 111d
Cleared Apr 11, 2018
Rafugen DBM
K180121 · MQV
Cellumed Co., Ltd.
Orthopedic · 85d
Cleared Apr 11, 2018
PET Digital Gating
K180318 · KPS
Ge Medical Systems, LLC
Radiology · 65d
Cleared Apr 11, 2018
Stablyx CMC Arthroplasty Implant System
K180744 · KYI
Skeletal Dynamics, LLC
Orthopedic · 20d
Cleared Apr 10, 2018
DTI-1 SLA IMPLANT SYSTEM
K170776 · DZE
Dti Implant Sistemleri Sanayi Ticaret...
Dental · 392d
Cleared Apr 10, 2018
Digital Automatic Wrist Blood Pressure Monitor MD4300
K171379 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 334d
Cleared Apr 10, 2018
NAJA™ Ligament Correction System
K172206 · OWI
Cousin Biotech Sas
Orthopedic · 263d
Cleared Apr 10, 2018
Mercury® Spinal System
K172967 · NKB
Spinal Elements, Inc.
Orthopedic · 196d
Cleared Apr 10, 2018
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect,...
K173384 · BTO
Smiths Medical Ads, Inc.
Anesthesiology · 162d
Cleared Apr 10, 2018
Eviva Stereotactic Guided Breast Biopsy System
K180233 · KNW
Hologic, Inc.
Gastroenterology & Urology · 71d
Cleared Apr 10, 2018
ACUVUE OASYS (senofilcon A) with Photochromic Additive
K180299 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 67d
Cleared Apr 10, 2018
AXIS 5.5 Lumbar Pedicle Screw System
K180301 · NKB
Axis Orthopaedics
Orthopedic · 67d
Cleared Apr 10, 2018
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES...
K180398 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 56d
Cleared Apr 10, 2018
Imager II Urology Torque Catheter
K180530 · KOD
Boston Scientific Corporation
Gastroenterology & Urology · 41d
Cleared Apr 09, 2018
OT EQUATOR
K171409 · NHA
Rhein 83 Srl
Dental · 329d
Cleared Apr 09, 2018
Hysteroscopy System
K172151 · HGH
Chongquin Jinshan Science &...
Obstetrics & Gynecology · 266d
Cleared Apr 09, 2018
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for...
K173386 · KGO
Lucenxia Prescience AG
General Hospital · 161d
Cleared Apr 09, 2018
Medline Cautery Electrode (PTFE)
K173889 · GEI
Medline Industries, Inc.
General & Plastic Surgery · 109d
Cleared Apr 09, 2018
Silicone Personal Lubricant, ALL-IN-ONE
K180083 · NUC
United Consortium
Obstetrics & Gynecology · 88d
Cleared Apr 09, 2018
Disposable Endoscopic Trocar
K180208 · GCJ
Fengh Medical Co., Ltd.
General & Plastic Surgery · 75d
Cleared Apr 09, 2018
ClotTriever Thrombectomy System
K180329 · QEW
Inari Medical, Inc.
Cardiovascular · 62d
Cleared Apr 09, 2018
Aurora Evacuator
K180372 · GEI
Rebound Therapeutics
General & Plastic Surgery · 56d