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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
55969–55992 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 2008
TIGER CANNULATED SCREW SYSTEM
K081510 · HWC
Trilliant Surgical, Ltd.
Orthopedic · 67d
Cleared Aug 04, 2008
MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM
K081859 · IYE
Sicel Technologies, Inc.
Radiology · 34d
Cleared Aug 04, 2008
KYMCO FORU, MODEL EQ35
K081980 · INI
Besteam Technology, Inc.
Physical Medicine · 24d
Cleared Aug 01, 2008
DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253
K073112 · NVE
Intuitive Surgical, Inc.
General Hospital · 270d
Cleared Aug 01, 2008
INTERCEPTOR PLUS CORONARY FILTER SYSTEMS
K073523 · NFA
Medtronic, Inc.
Cardiovascular · 231d
Cleared Aug 01, 2008
SCANSCOPE XT SYSTEM
K073677 · NQN
Aperio Technologies
Pathology · 217d
Cleared Aug 01, 2008
MODIFICATION TO ZILVER 635 BILIARY STENT
K080037 · FGE
Cook, Inc.
Gastroenterology & Urology · 207d
Cleared Aug 01, 2008
STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS
K081085 · NEU
Senorx, Inc.
General & Plastic Surgery · 107d
Cleared Aug 01, 2008
OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING
K081876 · KWD
Osteomed LP
Orthopedic · 30d
Cleared Aug 01, 2008
FIATLUX VISUALIZE
K082041 · LLZ
Fiatlux Imaging, Inc.
Radiology · 14d
Cleared Aug 01, 2008
CARRIAZO-PENDULAR MICROKERATOME
K082043 · HNO
Schwind Eye-Tech-Solutions GmbH & Co. KG
Ophthalmic · 14d
Cleared Aug 01, 2008
MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
K082045 · MHX
Spacelabs Medical, Inc.
Cardiovascular · 14d
Cleared Jul 31, 2008
STATMAP, MODEL 7200
K072109 · DXN
Ramsey Medical, Inc.
Cardiovascular · 365d
Cleared Jul 31, 2008
HEMOSIL D-DIMER
K073042 · DAP
Instrumentation Laboratory
Hematology · 276d
Cleared Jul 31, 2008
KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K080326 · DXN
Andon Health Co, Ltd.
Cardiovascular · 176d
Cleared Jul 31, 2008
ABL 80 CO-OX SYSTEM
K080370 · CHL
Sendx Medical, Inc.
Chemistry · 170d
Cleared Jul 31, 2008
CYTO-CHEX BCT
K080552 · GIM
Streck
Hematology · 154d
Cleared Jul 31, 2008
MDF REVISION HIP SYSTEM
K081124 · MEH
Smith & Nephew, Inc.
Orthopedic · 101d
Cleared Jul 31, 2008
PORCINE SURGICAL MESH
K081272 · FTM
Brennen Medical, LLC
General & Plastic Surgery · 87d
Cleared Jul 31, 2008
BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM
K081444 · DSI
Braemar, Inc.
Cardiovascular · 70d
Cleared Jul 31, 2008
SKYLINE 55
K081552 · MWI
Larsen & Toubro Limited
Cardiovascular · 58d
Cleared Jul 31, 2008
MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO
K081870 · DQA
GE Healthcare Finland Oy
Anesthesiology · 30d
Cleared Jul 31, 2008
GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH...
K081954 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 22d
Cleared Jul 31, 2008
APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES
K082031 · HJO
Appasamy Associates
Ophthalmic · 14d