Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
38425–38448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 17, 2014
Q-STATION
K140808 · LLZ
Philips Ultrasound, Inc.
Radiology · 16d
Cleared Apr 16, 2014
INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY...
K132620 · NDN
Pan Medical , Ltd.
Orthopedic · 238d
Cleared Apr 16, 2014
PVMED DDR 2430T
K133524 · MQB
Portavision Medical, LLC
Radiology · 152d
Cleared Apr 16, 2014
SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS
K133707 · MQL
Origio A/S
Obstetrics & Gynecology · 133d
Cleared Apr 16, 2014
AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION
K133783 · FIP
Ameriwater
Gastroenterology & Urology · 125d
Cleared Apr 16, 2014
ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S]
K133791 · NHA
Sterngold Dental, LLC
Dental · 124d
Cleared Apr 16, 2014
INTESS CERVICAL CAGE SYSTEM
K133815 · ODP
Kalitec Direct, LLC
Orthopedic · 121d
Cleared Apr 16, 2014
CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES)
K140092 · JOW
Currie Medical Specialties, Inc.
Cardiovascular · 92d
Cleared Apr 16, 2014
TRUEPATH CTO DEVICE
K140288 · PDU
Boston Scientific Corp
Cardiovascular · 70d
Cleared Apr 16, 2014
FREELITE HUMAN LAMBDA FREE KIT
K140396 · DEH
The Binding Site Group , Ltd.
Immunology · 57d