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

Filters: Cleared only ×
176,076 results
56065–56088 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 2008
COSMIC SYSTEM
K080841 · MNI
Ulrich GmbH & Co. KG
Orthopedic · 119d
Cleared Jul 23, 2008
INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM
K081070 · HIH
Interlace Medical, Inc.
Obstetrics & Gynecology · 99d
Cleared Jul 23, 2008
LEGION HINGE KNEE SYSTEM
K081111 · KRO
Smith & Nephew, Inc.
Orthopedic · 96d
Cleared Jul 23, 2008
BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM
K081177 · MAX
Blackstone Medical, Inc.
Orthopedic · 89d
Cleared Jul 23, 2008
FIXXSURE CROSS LINK
K081331 · MNH
Spineworks, LLC
Orthopedic · 72d
Cleared Jul 23, 2008
SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES
K081353 · HRS
Synthes (Usa)
Orthopedic · 70d
Cleared Jul 23, 2008
POWER ASPIRATOR, MODEL LS2 OR LS2DP
K081593 · QPB
Medical Device Resource Corp.
General & Plastic Surgery · 47d
Cleared Jul 22, 2008
PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION...
K073057 · GEI
Peak Surgical, Inc.
General & Plastic Surgery · 266d
Cleared Jul 22, 2008
ACCUFRAME
K081157 · NHA
Cagenix, Inc.
Dental · 90d
Cleared Jul 22, 2008
TRITANIUM ACETABULAR SHELL SYSTEM
K081171 · LPH
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared Jul 22, 2008
GORE VIABIL BILILARY ENDOPROSTHESIS
K081184 · FGE
W.L. Gore & Associates, Inc. Medical...
Gastroenterology & Urology · 88d
Cleared Jul 22, 2008
PLEXUR M
K081227 · MQV
Osteotech, Inc.
Orthopedic · 83d
Cleared Jul 22, 2008
BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818
K081323 · FCG
B-K Medical Aps
Gastroenterology & Urology · 71d
Cleared Jul 22, 2008
ORTHOPEDIATRICS PEDIPLATES SYSTEM
K081407 · HRS
OrthoPediatrics Corp.
Orthopedic · 64d
Cleared Jul 22, 2008
SAVI APPLICATOR KIT
K081677 · JAQ
Cianna Medical, Inc.
Radiology · 35d
Cleared Jul 22, 2008
CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM
K081776 · DXG
Omega Critical Care Limited
Cardiovascular · 29d
Cleared Jul 22, 2008
GE SIGNA MR ONCOLOGY PACKAGE
K081916 · LNH
Ge Medical Systems, LLC
Radiology · 15d
Cleared Jul 21, 2008
RAMP NT-PROBNP ASSAY
K063662 · NBC
Response Biomedical Corp.
Chemistry · 591d
Cleared Jul 21, 2008
AG-605 BLOOD GLUCOSE MONITORING SYSTEM
K073030 · NBW
Andon Health Co, Ltd.
Chemistry · 269d
Cleared Jul 21, 2008
MODIFICATION TO MAMMAPRINT
K080252 · NYI
Agendia BV
Pathology · 172d
Cleared Jul 21, 2008
ENDODRAPE(TM)
K080341 · KKX
Vortek Surgical, LLC
General Hospital · 164d
Cleared Jul 21, 2008
SONICWELD RX (RESORB-X)
K080862 · JEY
KLS-Martin L.P.
Dental · 116d
Cleared Jul 21, 2008
CAM STRUCTSURE PRECISION MILLED BARS
K080864 · NHA
Biomet 3i, Inc.
Dental · 115d
Cleared Jul 21, 2008
BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST
K081218 · IYE
It-V Medizintechnik, GmbH
Radiology · 82d