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
37513–37536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2014
MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO)
K132684 · LLZ
Medecom Sarl
Radiology · 268d
Cleared May 23, 2014
MYSPINE PEDICLE SCREW PLACEMENT GUIDES
K132788 · MNI
Medacta International
Orthopedic · 259d
Cleared May 23, 2014
NUTRA LIGHT BLUE
K132838 · OLP
Nutra Luxe MD, LLC
General & Plastic Surgery · 255d
Cleared May 23, 2014
VIBRALUNG ACOUSTICAL PERCUSSOR
K133057 · SDT
Westmed, Inc.
Anesthesiology · 238d
Cleared May 23, 2014
RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET
K133173 · JOH
Teleflexmedical, Inc.
Anesthesiology · 218d
Cleared May 23, 2014
MINNIE
K133405 · GEI
Elettronica Valseriana Srl
General & Plastic Surgery · 198d
Cleared May 23, 2014
SHERPA PAK TRANSPORTER
K133694 · KDN
Paragonix Technologies, Inc.
Gastroenterology & Urology · 171d
Cleared May 23, 2014
FMWAND HANDPIECE SE
K140384 · GEI
Domain Surgical, Inc.
General & Plastic Surgery · 98d
Cleared May 23, 2014
CORCAM HEART MONITOR
K140548 · DSI
Corcam Technologia, SA
Cardiovascular · 80d
Cleared May 23, 2014
WALLFLEX BILIARY RX STENT SYSTEM
K140630 · FGE
Boston Scientific
Gastroenterology & Urology · 73d
Cleared May 23, 2014
APLIO ARTIDA, V3.2
K140729 · IYN
Toshiba America Medical Systems, In.C
Radiology · 60d
Cleared May 23, 2014
VIVID T8/VIVID T8 PRO
K141067 · IYN
Ge Healthcare
Radiology · 29d
Cleared May 23, 2014
TIGHTRAIL MINI
K141131 · DRE
Spectranetics, Inc.
Cardiovascular · 22d
Cleared May 22, 2014
SYNERGY
K123876 · NPM
Odontit S.A.
Dental · 521d
Cleared May 22, 2014
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
K131588 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 356d
Cleared May 22, 2014
EV1000 CLINICAL PLATFORM
K131892 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 331d
Cleared May 22, 2014
SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE
K132681 · MEG
Sol-Millennium Medical, Inc.
General Hospital · 267d
Cleared May 22, 2014
CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT,...
K133121 · QSY
Sam Medical Products
General & Plastic Surgery · 234d
Cleared May 22, 2014
ZOLL X SERIES
K133269 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 210d
Cleared May 22, 2014
NEXUS NIS-6P LUER ACTIVATED DEVICE
K133351 · FPA
Nexus Medical, LLC
General Hospital · 203d
Cleared May 22, 2014
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM
K133790 · NBW
Andon Health Co, Ltd.
Chemistry · 164d
Cleared May 22, 2014
ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER
K140027 · JWH
Materialise NV
Orthopedic · 136d
Cleared May 22, 2014
CARPENTIER BI-CAVAL FEMORAL CANNULA
K140192 · DWF
Medtronic, Inc.
Cardiovascular · 115d
Cleared May 22, 2014
ISE INDIRECT NA, K, C1 FOR GEN 2
K140373 · JGS
Roche Diagnostics
Chemistry · 97d