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
22225–22248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 2019
PureLift
K190269 · NFO
Xtreem Pulse, LLC
Neurology · 201d
Cleared Aug 28, 2019
Delta 3300
K190437 · DRL
Netech Corporation
Cardiovascular · 187d
Cleared Aug 28, 2019
Signature Ceramic Femoral Head
K190704 · LZO
Signature Orthopaedics Pty, Ltd.
Orthopedic · 163d
Cleared Aug 28, 2019
Conformis BeneFIT Hip System
K190904 · LPH
Conformis, Inc.
Orthopedic · 142d
Cleared Aug 28, 2019
BIOLOX CONTOURA Ceramic Femoral Head
K191399 · LZO
Total Joint Othopedics, Inc.
Orthopedic · 96d
Cleared Aug 28, 2019
EXETER Centralizer, EXETER 2.5mm Plug
K191414 · JDI
Stryker Orthopaedics
Orthopedic · 92d
Cleared Aug 28, 2019
Interphalangeal Joint Fusion Device Range
K191424 · HWC
Neosteo
Orthopedic · 91d
Cleared Aug 28, 2019
ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
K191533 · CDZ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 79d
Cleared Aug 28, 2019
Implantcast ic-Bipolar Head System
K191569 · KWY
Implantcast GmbH
Orthopedic · 76d
Cleared Aug 28, 2019
Omnia Medical VBR
K191778 · PLR
Omnia Medical, LLC
Orthopedic · 57d
Cleared Aug 28, 2019
AP50/30 Insufflator with Insuflow Port
K191780 · HIF
Lexion Medical, LLC
Obstetrics & Gynecology · 57d
Cleared Aug 28, 2019
Curiteva Pedicle Screw System
K191810 · NKB
Curiteva, Inc.
Orthopedic · 54d
Cleared Aug 27, 2019
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with...
K191077 · KFM
Medtronic, Inc.
Cardiovascular · 126d
Cleared Aug 27, 2019
Plexus
K191107 · JOW
Alleva Medical (D.G), Ltd.
Cardiovascular · 123d
Cleared Aug 26, 2019
Navigated T2 STRATOSPHERE Inserters and Navigated Templates
K191039 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 129d
Cleared Aug 26, 2019
IPS e.max CAD Abutment Solutions- extra systems
K191382 · NHA
Ivoclar Vivadent, AG
Dental · 95d
Cleared Aug 26, 2019
Halley resin system
K191427 · EBI
Dentsply Sirona
Dental · 89d
Cleared Aug 26, 2019
AXIOS Stent and Electrocautery Enhanced Delivery System
K192043 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 26d
Cleared Aug 25, 2019
810nm Diode Laser System
K183122 · GEX
Shanghai Wonderful Opto-Electrics...
General & Plastic Surgery · 289d
Cleared Aug 23, 2019
Acare Suction Unit
K182950 · JCX
Acare Technology Co., Ltd.
General & Plastic Surgery · 304d
Cleared Aug 23, 2019
CustMBite Dental Guard
K183315 · OBR
Dental Choice Holdings, LLC
Dental · 266d
Cleared Aug 23, 2019
Efficient Care 3D Planning
K183544 · LLZ
Orthosoft Inc. (d/b/a) Zimmer CAS
Radiology · 246d
Cleared Aug 23, 2019
Vyntus/SentrySuite Product Line
K183567 · BZC
Vyaire Medical
Anesthesiology · 245d
Cleared Aug 23, 2019
FUJIFILM Bronchoscope
K183607 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 240d