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
39625–39648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 2013
PIPELINE KNEE SYSTEM
K132046 · JWH
Pipeline Orthopedics
Orthopedic · 83d
Cleared Sep 23, 2013
DESARA MESH, DESARA BLUE
K132069 · OTN
Caldera Medical, Inc.
Gastroenterology & Urology · 82d
Cleared Sep 23, 2013
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K132508 · OZE
Centers For Disease Control and...
Microbiology · 42d
Cleared Sep 23, 2013
EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
K132672 · LNS
Dornier Medtech America
Gastroenterology & Urology · 27d
Cleared Sep 23, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132692 · PSZ
Becton, Dickinson and Company
Microbiology · 25d
Cleared Sep 20, 2013
SINUFLUSH LAVAGE SYSTEM
K131177 · KAR
Hedgepath, LLC
Ear, Nose, Throat · 148d
Cleared Sep 20, 2013
MROZ REVERSE OSMOSIS SYSTEM
K131622 · FIP
Ameriwater
Gastroenterology & Urology · 109d
Cleared Sep 20, 2013
COROENT SINGLE TAB SYSTEM
K131723 · OVD
Nuvasive, Inc.
Orthopedic · 100d
Cleared Sep 20, 2013
MULTICHEM IA AND IA PLUS
K132091 · JJY
Techno-Path Manufacturing , Ltd.
Chemistry · 74d
Cleared Sep 20, 2013
MULTICHEM WBT
K132174 · DIF
Techno-Path Manufacturing , Ltd.
Toxicology · 67d
Cleared Sep 20, 2013
PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA
K132203 · HIF
Lexion Medical, LLC
Obstetrics & Gynecology · 66d
Cleared Sep 20, 2013
MICROPLEX COIL SYSTEM (MCS), VFC
K132317 · HCG
MicroVention, Inc.
Neurology · 57d
Cleared Sep 20, 2013
IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000...
K132391 · JJX
Siemens Helathcare Diagnostics, Inc.
Immunology · 50d
Cleared Sep 19, 2013
VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
K122143 · NQN
Ventana Medical Systems, Inc.
Pathology · 427d
Cleared Sep 19, 2013
APD LUER-LOCK ADAPTER
K124024 · KDJ
Fresensius Medical Care North America
Gastroenterology & Urology · 265d
Cleared Sep 19, 2013
PHILIPS HERCEPTEST DIGITAL SCORE
K130021 · OEO
Philips Medical Systems Nederland B.V.
Pathology · 259d
Cleared Sep 19, 2013
BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200...
K130053 · MVM
Bio-Rad Laboratories, Inc.
Immunology · 247d
Cleared Sep 19, 2013
ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
K130810 · HWC
Zimmer, Inc.
Orthopedic · 178d
Cleared Sep 19, 2013
RENOVIS BIPOLAR HIP SYSTEM
K131354 · KWY
Renovis Surgical Technologies, LLC
Orthopedic · 132d
Cleared Sep 19, 2013
AUTOLAP SYSTEM
K131375 · GCJ
Mst - Medical Surgery Technologies ,...
General & Plastic Surgery · 129d
Cleared Sep 19, 2013
EQUINOX CO2 LASER
K131903 · ONG
Eclipse Aesthetics, LLC
General & Plastic Surgery · 86d
Cleared Sep 19, 2013
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
K132420 · DQY
Reflow Medical
Cardiovascular · 45d
Cleared Sep 19, 2013
OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00
K132479 · MAX
Interventional Spine, Inc.
Orthopedic · 42d
Cleared Sep 19, 2013
Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM...
K132513 · MBI
ArthroCare Corporation
Orthopedic · 38d