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
77497–77520 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2002
DILATING TIP OBTURATOR
K012884 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 142d
Cleared Jan 17, 2002
MODIFICATION OF NC-STAT
K013459 · JXE
Neurometrix, Inc.
Neurology · 91d
Cleared Jan 17, 2002
SWIFT LOW PROFILE CUP (PRO CUP)
K013460 · HDB
Swift Delivery Products
Obstetrics & Gynecology · 91d
Cleared Jan 17, 2002
NLITE SYSTEM,MODEL A00-1025
K013461 · GEX
Icn Photonics , Ltd.
General & Plastic Surgery · 91d
Cleared Jan 17, 2002
TOCO LITE, MODEL TD-01
K013477 · HFM
Ventrex, Inc.
Obstetrics & Gynecology · 90d
Cleared Jan 17, 2002
MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH...
K013485 · DXN
Microlife Corp.
Cardiovascular · 90d
Cleared Jan 17, 2002
CEMENTED CALCAR HIP SYSTEM
K013490 · LPH
Encore Orthopedics, Inc.
Orthopedic · 87d
Cleared Jan 17, 2002
CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN...
K013498 · LYY
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 87d
Cleared Jan 17, 2002
DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE
K013513 · HRX
Pain Concepts, Inc.
Orthopedic · 87d
Cleared Jan 17, 2002
SIMPLE
K013519 · KLE
Bisco, Inc.
Dental · 86d
Cleared Jan 17, 2002
ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS
K013539 · DXN
Rossmax International , Ltd.
Cardiovascular · 85d
Cleared Jan 17, 2002
POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN...
K013554 · LYY
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 84d
Cleared Jan 17, 2002
MAGICFIL
K013571 · EBF
Dmg USA, Inc.
Dental · 80d
Cleared Jan 17, 2002
ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE...
K013583 · DXN
Rossmax International , Ltd.
Cardiovascular · 79d
Cleared Jan 17, 2002
PERMACOL
K013625 · FTM
Tissue Science Laboratories, Plc
General & Plastic Surgery · 73d
Cleared Jan 17, 2002
GLOBAL HEALTHCARE VAGINAL SPECULUM
K013835 · HIB
Dynascend Consulting Int'L, LLC
Obstetrics & Gynecology · 59d
Cleared Jan 17, 2002
3DFIS, MODEL IES-FL-101
K013841 · LLZ
3Dsharp, Inc.
Radiology · 58d
Cleared Jan 17, 2002
SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208
K013870 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 57d
Cleared Jan 17, 2002
SIMPLICITY STARPLUS SOFT INFUSION SET
K014061 · FPA
Sterling Medivations, Inc.
General Hospital · 38d
Cleared Jan 17, 2002
SIMPLICITY EASY ACCESS INFUSION SET
K014062 · FPA
Sterling Medivations, Inc.
General Hospital · 38d
Cleared Jan 17, 2002
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY...
K014136 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 31d
Cleared Jan 17, 2002
MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM,...
K014145 · MQP
Interpore Cross Intl.
Orthopedic · 30d
Cleared Jan 17, 2002
SELF-DRILLING RADIOGRAPHIC MARKER
K014148 · NEU
Walter Lorenz Surgical, Inc.
General & Plastic Surgery · 30d
Cleared Jan 17, 2002
HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A
K014157 · MKJ
Philips Medical Systems
Cardiovascular · 29d