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
40441–40464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 2013
EMORY CARDIAC TOOLBOX 3.2
K130902 · KPS
Syntermed, Inc.
Radiology · 74d
Cleared Jun 14, 2013
OMNICUT RESECTION BLADE
K130912 · HRX
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 73d
Cleared Jun 14, 2013
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K130992 · IYE
Philips Medical Systems (Cleveland),...
Radiology · 65d
Cleared Jun 14, 2013
NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY
K130995 · GEH
Nuance Medical, LLC
General & Plastic Surgery · 65d
Cleared Jun 14, 2013
TORC BODY
K131291 · NGX
Johari Digital Healthcare , Ltd.
Physical Medicine · 39d
Cleared Jun 14, 2013
PG-800A SERIES
K131569 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 15d
Cleared Jun 13, 2013
ENTERAL NUTRITION WARMER
K122449 · LGZ
Acacia, Inc.
General Hospital · 304d
Cleared Jun 13, 2013
SHASER V-MINI HAIR REMOVAL SYSTEM
K130015 · ONF
Shaser, Inc.
General & Plastic Surgery · 161d
Cleared Jun 13, 2013
GUIDEWIRE, PURSUER SERIES
K130104 · DQX
Oscor, Inc.
Cardiovascular · 149d
Cleared Jun 13, 2013
ORTHOSENSOR KNEE BALANCER
K130380 · ONN
Orthosensor, Inc.
Orthopedic · 119d
Cleared Jun 13, 2013
PLATEAU SPACER SYSTEM TITANIUM
K130630 · MAX
Life Spine, Inc.
Orthopedic · 97d
Cleared Jun 13, 2013
STANDARD CONTACT LENS CASE
K130753 · LRX
Watchdog Group, LC
Ophthalmic · 86d
Cleared Jun 13, 2013
QUANTUM DENTAL IMPLANT SYSTEM
K130787 · DZE
Quantum Bioengineering, Ltd.
Dental · 84d
Cleared Jun 13, 2013
PIPELINE TOTAL HIP SYSTEM
K131237 · LPH
Pipeline Orthopedics
Orthopedic · 43d
Cleared Jun 12, 2013
VUSION CS PLUS
K122588 · ODP
Ortho Development Corp.
Orthopedic · 292d
Cleared Jun 12, 2013
AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE
K122973 · HEX
Medgyn Products, Inc.
Obstetrics & Gynecology · 259d
Cleared Jun 12, 2013
EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
K123261 · LKO
Euroimmun US
Immunology · 237d
Cleared Jun 12, 2013
MINT
K130191 · NEW
Hans Biomed Corporation
General & Plastic Surgery · 138d
Cleared Jun 12, 2013
NEXUS TKO-6P LUER ACTIVATED DEVICE
K130416 · FPA
Nexus Medical, LLC
General Hospital · 113d
Cleared Jun 12, 2013
SMR 3-PEGS GLENOIDS
K130642 · KWS
Lima Corporate S.P.A.
Orthopedic · 93d
Cleared Jun 12, 2013
Z-800 INFUSION SYSTEM
K130690 · FRN
Zyno Medical, LLC
General Hospital · 90d
Cleared Jun 11, 2013
PREVENT SEAL
K122521 · EBC
Itena Clinical
Dental · 295d
Cleared Jun 11, 2013
ENGLER 25K SERIES ULTRASONIC INSERTS
K122748 · ELC
Engler Engineering Corp.
Dental · 277d
Cleared Jun 11, 2013
T3
K123292 · NIE
Medcomp
Gastroenterology & Urology · 232d