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
23953–23976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 2018
1688 Camera Control Unit
K182160 · GCJ
Stryker
General & Plastic Surgery · 88d
Cleared Nov 05, 2018
PREMIER Platinum HpSA PLUS
K182559 · LYR
Meridian Bioscience, Inc.
Microbiology · 49d
Cleared Nov 02, 2018
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus...
K180180 · MQR
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 283d
Cleared Nov 02, 2018
Sheridan Endobronchial Tubes
K180253 · CBI
Teleflex Medical
Anesthesiology · 276d
Cleared Nov 02, 2018
Invia White Foam NPWT
K180415 · OMP
Medela AG
General & Plastic Surgery · 260d
Cleared Nov 02, 2018
Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under...
K180601 · OAS
Villa Sistemi Medicali S.P.A.
Radiology · 240d
Cleared Nov 02, 2018
Sterile Nitrile Powder Free Examination Glove Tested for Use with...
K180786 · LZA
Hartalega Sdn Bhd
General Hospital · 221d
Cleared Nov 02, 2018
ClearPoint System
K181195 · ORR
Mri Interventions, Inc.
Neurology · 182d
Cleared Nov 02, 2018
Vygon Midline 3 Fr SL Catheter
K181208 · PND
Vygon USA
General Hospital · 179d
Cleared Nov 02, 2018
Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
K181403 · OWB
Ge Healthcare
Radiology · 157d
Cleared Nov 02, 2018
Afina
K181501 · NFJ
Neurovision Imaging, LLC
Ophthalmic · 148d
Cleared Nov 02, 2018
Panta 2 Arthrodesis Nail System
K181639 · HSB
Integra LifeSciences Corporation
Orthopedic · 134d
Cleared Nov 02, 2018
Spinal Elements Ti-Bond coated devices
K181837 · MAX
Spinal Elements, Inc.
Orthopedic · 115d
Cleared Nov 02, 2018
Interlude 100% Cotton Tampon
K181911 · HEB
Albaad Fem
Obstetrics & Gynecology · 108d
Cleared Nov 02, 2018
Mazor X System (Mazor X Stealth Edition)
K182077 · OLO
Mazor Robotics , Ltd.
Orthopedic · 93d
Cleared Nov 02, 2018
Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy...
K182096 · LZA
Owens & Minor Halyard, Inc.
General Hospital · 91d
Cleared Nov 02, 2018
NavLock Trackers, Robotic Reference Frame
K182104 · OLO
Medtronic Navigation
Orthopedic · 91d
Cleared Nov 02, 2018
CDI Blood Parameter Monitoring System 550
K182110 · DRY
Terumo Cardiovascular Systems...
Cardiovascular · 88d
Cleared Nov 02, 2018
CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
K182121 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Nov 02, 2018
Wrist Blood Pressure Monitor Model BP6100
K182127 · DXN
Omron Healthcare, Inc.
Cardiovascular · 88d
Cleared Nov 02, 2018
Cellene CO2 Laser System
K182270 · GEX
Bio-Med USA, Inc.
General & Plastic Surgery · 72d
Cleared Nov 02, 2018
Dexcom Pro Q Continuous Glucose Monitoring System
K182405 · QDL
Dexcom, Inc.
Chemistry · 59d
Cleared Nov 02, 2018
Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System
K182427 · IYN
Canon Medical Systems Corporation
Radiology · 57d
Cleared Nov 02, 2018
MTS Eravacycline 0.002 - 32 µg/mL
K182557 · JWY
Liofilchem S. R. L.
Microbiology · 46d