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
55033–55056 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2008
STERI-LUB LUBRICATION GEL
K083189 · KMJ
Avail Medical Products, Inc.
General Hospital · 23d
Cleared Nov 21, 2008
16CH AI BREAST COILS 1.5 T AND 3 T
K083255 · MOS
Rapid Biomedical GmbH
Radiology · 17d
Cleared Nov 20, 2008
FACTOR VIII ANTIBODY SCREEN
K082205 · GGP
Genetic Testing Institute
Hematology · 107d
Cleared Nov 20, 2008
SNTRYPACS
K082240 · LLZ
Qstar Technologies, Inc.
Radiology · 105d
Cleared Nov 20, 2008
AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM
K082284 · JCT
Alveolus, Inc.
General & Plastic Surgery · 101d
Cleared Nov 20, 2008
VERICORE IMPLANT ABUTMENTS
K082299 · NHA
Whip-Mix Corp.
Dental · 100d
Cleared Nov 20, 2008
ENABLER-P SUPPORT CATHETER
K082339 · DQY
Endocross, Ltd.
Cardiovascular · 98d
Cleared Nov 20, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE...
K082538 · LON
Becton, Dickinson & CO
Microbiology · 79d
Cleared Nov 20, 2008
EVERCROSS .035 OTW PTA DILATATION CATHETER
K082579 · DQY
Ev3, Inc.
Cardiovascular · 76d
Cleared Nov 20, 2008
CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23
K082628 · LLZ
Circle Cardiovascular Imaging, Inc.
Radiology · 72d
Cleared Nov 20, 2008
INFINITT XELIS
K082990 · LLZ
Infinitt Co., Ltd.
Radiology · 44d
Cleared Nov 20, 2008
BIOLOX DELTA CERAMIC FEMORAL HEAD
K082991 · LZO
Aesculap Implant Systems, Inc.
Orthopedic · 44d
Cleared Nov 20, 2008
STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY,...
K083076 · JXG
Medtronic Neurosurgery
Neurology · 35d
Cleared Nov 19, 2008
EMG TRITON -COMP,MODEL NCA01-XXX SERIES
K072634 · BTI
Emg Technology Co., Ltd.
Anesthesiology · 428d
Cleared Nov 19, 2008
NITI-S BILIARY STENT
K073667 · FGE
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 329d
Cleared Nov 19, 2008
SH14 HEMOCONCENTRATOR
K081313 · KDI
Sorin Group Italia S.R.L.
Gastroenterology & Urology · 194d
Cleared Nov 19, 2008
THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS
K081380 · KWQ
K2m, Inc.
Orthopedic · 187d
Cleared Nov 19, 2008
THERAGEM PROFESSIONAL T1002
K081505 · ILY
Medica Health, Ltd.
Physical Medicine · 174d
Cleared Nov 19, 2008
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5
K082714 · JJY
Aalto Scientific, Ltd.
Chemistry · 63d
Cleared Nov 19, 2008
STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331
K082773 · IYE
Standard Imaging, Inc.
Radiology · 58d
Cleared Nov 19, 2008
MULTLINK CABLE AND LEADWIRE SYSTEM
K082851 · DSA
Ge Medical Systems Information...
Cardiovascular · 51d
Cleared Nov 19, 2008
GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP...
K083100 · NHA
Nobel Biocare USA, LLC
Dental · 30d
Cleared Nov 18, 2008
NON-CONTACT TONOMETER, MODEL FT-1000
K073087 · HKX
Tomey Corporation
Ophthalmic · 383d
Cleared Nov 18, 2008
LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG
K081685 · MXJ
DiaSorin, Inc.
Microbiology · 154d