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
37825–37848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 2014
JULIET OL
K140474 · MAX
Spineart
Orthopedic · 52d
Cleared Apr 18, 2014
ORTHOSORB LS
K140625 · OVZ
Biomet, Inc.
Orthopedic · 38d
Cleared Apr 17, 2014
UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
K131189 · CFR
Beckman Coulter, Inc.
Chemistry · 356d
Cleared Apr 17, 2014
SMART (SMART-D, SMART-DX)
K131660 · LXJ
Bts S.P.A.
Physical Medicine · 315d
Cleared Apr 17, 2014
HC-1 AND HC-1 CLASSIC
K131852 · KPL
Transcendencias Comerciales SL Transcom
Gastroenterology & Urology · 300d
Cleared Apr 17, 2014
DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES
K131962 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 294d
Cleared Apr 17, 2014
ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)
K132547 · NDC
Monarch Medical Technologies
General Hospital · 247d
Cleared Apr 17, 2014
ICONN ANSWER SUTURE ANCHOR
K132724 · MBI
Iconn Orthopedics, LLC
Orthopedic · 230d
Cleared Apr 17, 2014
FLIP INTRODUCER ACCESS KIT
K132789 · DYB
Vascular Solutions, Inc.
Cardiovascular · 223d
Cleared Apr 17, 2014
ADVATX
K132976 · GEX
Advalight Aps
General & Plastic Surgery · 206d
Cleared Apr 17, 2014
NEOV DIODE LASER FAMILY
K133006 · GEX
G.N.S Neolaser , Ltd.
General & Plastic Surgery · 204d
Cleared Apr 17, 2014
SPEED ARC
K133270 · JDR
Biomedical Enterprises, Inc.
Orthopedic · 176d
Cleared Apr 17, 2014
STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD...
K133421 · NHA
Straumann USA, LLC
Dental · 160d
Cleared Apr 17, 2014
RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED...
K133522 · NBW
Bionime Coporation
Chemistry · 153d
Cleared Apr 17, 2014
SOMATOM FORCE
K133589 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 146d
Cleared Apr 17, 2014
AIS MODULIFT VBR SYSTEM
K133802 · MQP
Aesculap Implant System, Inc.
Orthopedic · 125d
Cleared Apr 17, 2014
NUFACE MINI DEVICE
K133823 · NFO
Carol Cole Company
Neurology · 121d
Cleared Apr 17, 2014
INITARY BETTER BLADDER-PEDIATRIC
K140321 · DTN
Circulatory Technology, Inc.
Cardiovascular · 58d
Cleared Apr 17, 2014
PARALOCK PLATING SYSTEM / TUFFNEK SCREW
K140397 · HRS
Paragon 28
Orthopedic · 58d
Cleared Apr 17, 2014
DESTINO TWIST, STEERABLE GUIDING SHEATH
K140406 · DYB
Oscor, Inc.
Cardiovascular · 58d
Cleared Apr 17, 2014
LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE
K140495 · GEI
Boston Scientific Corp
General & Plastic Surgery · 49d
Cleared Apr 17, 2014
ZIP MIS INTERSPINOUS FUSION SYSTEM
K140715 · PEK
Aurora Spine, Inc.
Orthopedic · 27d
Cleared Apr 17, 2014
ENCORE 26 ADVANTAGE KIT
K140745 · MAV
Boston Scientific Corp
Cardiovascular · 23d
Cleared Apr 17, 2014
VARIAX 2 SYSTEM
K140769 · HRS
Stryker Trauma AG
Orthopedic · 21d