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
41473–41496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 2013
HYDRASOLVE LIPOPLASTY SYSTEM
K130152 · MUU
Andrew Technologies, LLC
General & Plastic Surgery · 86d
Cleared Apr 18, 2013
EPICAGE INTERBODY FUSION DEVICE
K130548 · MAX
Alphatec Spine, Inc.
Orthopedic · 45d
Cleared Apr 18, 2013
ENDO GIA RELOAD
K130717 · GDW
Covidien, Formerly US Surgical A...
General & Plastic Surgery · 34d
Cleared Apr 18, 2013
MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR
K130770 · LLZ
Nec Display Solutions , Ltd.
Radiology · 29d
Cleared Apr 18, 2013
MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR
K130772 · LLZ
Nec Display Solutions , Ltd.
Radiology · 29d
Cleared Apr 18, 2013
SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T
K130883 · MQB
Sedecal., Sa.
Radiology · 20d
Cleared Apr 17, 2013
HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER
K121770 · CAF
Headstar Medical Products Co., Ltd.
Anesthesiology · 306d
Cleared Apr 17, 2013
PLASMATRODE SALINE SAFE TUR ELECTRODE
K122716 · GEI
Cook Ireland, Ltd.
General & Plastic Surgery · 224d
Cleared Apr 17, 2013
COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT
K123083 · DWJ
Covidien
Cardiovascular · 198d
Cleared Apr 17, 2013
M300 & M400
K123290 · ITI
Permobil AB
Physical Medicine · 177d
Cleared Apr 17, 2013
VS3
K123467 · GCJ
Visionsense, Ltd.
General & Plastic Surgery · 159d
Cleared Apr 17, 2013
QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH...
K123593 · LKP
Inova Diagnostics, Inc.
Immunology · 147d
Cleared Apr 17, 2013
TRUECPR COACHING DEVICE
K123597 · LIX
Physio-Control, Inc.
Cardiovascular · 147d
Cleared Apr 17, 2013
INSTAFLO BOWEL CATHETER SYSTEM KIT
K123804 · KNT
Hollister, Inc.
Gastroenterology & Urology · 128d
Cleared Apr 17, 2013
STRIVE DUAL ZONE PEAK FLOW METER
K123945 · BZH
Monaghan Medical Corp.
Anesthesiology · 117d
Cleared Apr 17, 2013
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK...
K124009 · JJY
Diamond Diagnostics, Inc.
Chemistry · 111d
Cleared Apr 17, 2013
SLEEP PROFILER
K130007 · OLZ
Advanced Brain Monitoring, Inc.
Neurology · 105d
Cleared Apr 17, 2013
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION
K130535 · NBW
Agamatrix, Inc.
Chemistry · 47d
Cleared Apr 17, 2013
MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.
K130725 · FOS
Covidien Lp, Formerly Registered AS...
General Hospital · 30d
Cleared Apr 17, 2013
LTN - LAPAROSCOPIC SURGICAL MESH
K130817 · OXK
Lifecell Corp.
General & Plastic Surgery · 23d
Cleared Apr 16, 2013
SIGN PEDIATRIC FIN NAIL
K122823 · HSB
Sign Fracture Care International
Orthopedic · 214d
Cleared Apr 16, 2013
BRIGADE STANDALONE SYSTEM
K123045 · OVD
Nuvasive, Inc.
Orthopedic · 197d
Cleared Apr 16, 2013
PAINMASTER MCT PATCH
K130114 · NUH
Newmark, Inc.
Neurology · 90d
Cleared Apr 16, 2013
PEERSCOPE SYSTEM
K130718 · FDF
Peermedical , Ltd.
Gastroenterology & Urology · 29d