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
25705–25728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 2018
GC Fuji Direct
K172382 · EMA
GC America, Inc.
Dental · 237d
Cleared Apr 02, 2018
Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax
K173639 · OWB
Siemens Medi Cal Solutions, Inc.
Radiology · 129d
Cleared Apr 02, 2018
K-D Balance
K173669 · LXV
King-Devick Technologies, Inc.
Ear, Nose, Throat · 123d
Cleared Apr 02, 2018
Microcyn Antimicrobial Hydrogel
K173896 · FRO
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery · 101d
Cleared Apr 02, 2018
CREO® Stabilization System
K180210 · NKB
Globus Medical, Inc.
Orthopedic · 68d
Cleared Apr 02, 2018
Varian Head Frame
K180586 · IYE
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Mar 30, 2018
UF(II) Implant System
K170608 · DZE
Dio Corporation
Dental · 394d
Cleared Mar 30, 2018
AMSure® Enteral Feeding Syringe with ENFit Tip
K171857 · PNR
Amsino International, Inc.
Gastroenterology & Urology · 282d
Cleared Mar 30, 2018
Dr’s Finder NEO
K171867 · LQY
Good Doctors Co., Ltd.
Dental · 281d
Cleared Mar 30, 2018
Dimesol Tubing Sets for Hemodialysis
K171952 · FJK
Dimesol, Inc.
Gastroenterology & Urology · 274d
Cleared Mar 30, 2018
Performer Guiding Sheath
K171988 · DYB
Cook Incorporated
Cardiovascular · 270d
Cleared Mar 30, 2018
Mandril Wire Guide
K171997 · DQX
Cook Incorporated
Cardiovascular · 270d
Cleared Mar 30, 2018
ImmuLisa Enhanced RNA POL III Antibody ELISA
K172078 · NYO
Immco Diagnostics, Inc.
Immunology · 263d
Cleared Mar 30, 2018
OLYMPUS URF-V2/V2R
K172246 · FGB
Olympus Medical Systems Corp.
Gastroenterology & Urology · 247d
Cleared Mar 30, 2018
eego amplifiers
K172312 · GWL
Eemagine Medical Imaging Solutions GmbH
Neurology · 241d
Cleared Mar 30, 2018
Bleep DreamPort
K172335 · BZD
Snapcpap
Anesthesiology · 240d
Cleared Mar 30, 2018
Nipro Syringe
K173029 · FMF
Nipro Medical Corporation
General Hospital · 183d
Cleared Mar 30, 2018
Straumann Variobase for Crown AS
K173379 · NHA
Institut Straumann AG
Dental · 151d
Cleared Mar 30, 2018
RADspeed fit
K173517 · KPR
Shimadzu Corporation
Radiology · 136d
Cleared Mar 30, 2018
Merit Pursue Microcatheter
K173548 · DQY
Merit Medical Systems, Inc.
Cardiovascular · 134d
Cleared Mar 30, 2018
MAGNETOM Vida with Compressed Sensing GRASP-VIBE
K173617 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 128d
Cleared Mar 30, 2018
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition...
K173630 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 126d
Cleared Mar 30, 2018
syngo.CT Coronary Analysis
K173637 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 126d
Cleared Mar 30, 2018
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon
K173789 · IWB
Elekta Instrument AB
Radiology · 106d