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
40081–40104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 2013
NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND...
K132734 · FPA
Baxter Healthcare Corp
General Hospital · 35d
Cleared Oct 08, 2013
QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
K132829 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 29d
Cleared CT Oct 07, 2013
VISI MOBILE MONITORING SYSTEM
K130709 · MWI
Sotera Wireless, Inc.
Cardiovascular · 206d
Cleared Oct 07, 2013
KYMCO EQ20C SCOOTER
K130940 · INI
Kwang Yang Motor Co., Ltd.
Physical Medicine · 186d
Cleared Oct 07, 2013
TRELLIS COLLAGEN RIBBON
K131143 · OWY
Wrightmedicaltechnologyinc
Orthopedic · 167d
Cleared Oct 07, 2013
ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE...
K131201 · FGE
Cook, Inc.
Gastroenterology & Urology · 161d
Cleared Oct 07, 2013
V8 SP NORMAL CONTROL, ABNORMAL CONTROL
K131479 · JJY
Helena Laboratories
Immunology · 138d
Cleared Oct 07, 2013
PHILIPS PIXIUM 4343RC
K131483 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 137d
Cleared Oct 07, 2013
INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
K131645 · DKZ
Alfa Scientific Designs, Inc.
Toxicology · 124d
Cleared Oct 07, 2013
HEM-6221
K131749 · DXN
Omron Healthcare, Inc.
Cardiovascular · 115d
Cleared Oct 07, 2013
CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM
K131769 · MBI
Pivot Medical, Inc.
Orthopedic · 112d
Cleared Oct 07, 2013
CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES
K131771 · FLL
Thermomedics, Inc.
General Hospital · 112d
Cleared Oct 07, 2013
ESOFLIP BALLOON DILATION CATHETER
K132337 · PID
Crospon, Ltd.
Gastroenterology & Urology · 73d
Cleared Oct 07, 2013
ESTECH COBRA(R) GENESIS BIPOLAR CLAMP
K133017 · GEI
Estech, Inc.
General & Plastic Surgery · 11d
Cleared Oct 04, 2013
ISCHEMA VIEW RAPID
K121447 · LLZ
Ischemaview, Inc.
Radiology · 507d
Cleared Oct 04, 2013
INNER PEACE
K122800 · HIR
Kamabry, Inc., Dba Inner Peace For Women
Gastroenterology & Urology · 387d
Cleared Oct 04, 2013
PATHFAST CK-MB-II CALIBRATORS
K130628 · JIT
Mitsubishi Chemical Medience Corporation
Chemistry · 210d
Cleared Oct 04, 2013
SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT
K131709 · LRC
Arthrocare Corp.
Ear, Nose, Throat · 115d
Cleared Oct 04, 2013
AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G,...
K131820 · HRX
Care Fusion
Orthopedic · 106d
Cleared Oct 04, 2013
MICROPLEX COIL SYSTEM (MCS)
K131948 · HCG
MicroVention, Inc.
Neurology · 99d
Cleared Oct 04, 2013
XPRESS MULTI-SINUS DILATION TOOL
K132440 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 59d
Cleared Oct 04, 2013
VITAHEAT PATIENT WARMING SYSTEM
K132454 · DWJ
Vitaheat Medical, LLC
Cardiovascular · 59d
Cleared Oct 04, 2013
THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
K132645 · GAD
Medtronic, Inc.
General & Plastic Surgery · 42d
Cleared Oct 04, 2013
STAXX IBL SYSTEM
K132719 · MAX
Spine Wave, Inc.
Orthopedic · 35d