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
47377–47400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 2011
PRO-V COAT
K103514 · EBG
Bisco, Inc.
Dental · 176d
Cleared May 25, 2011
SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR...
K103692 · HIF
Surgiquest, Inc.
Obstetrics & Gynecology · 159d
Cleared May 25, 2011
MUSE CARDIOLOGY INFORMATION SYSTEM
K110132 · DQK
Ge Medical Systems Information...
Cardiovascular · 127d
Cleared May 25, 2011
SYNCHRON MULTI CALIBRATOR
K110251 · JIX
Beckman Coulter, Inc.
Chemistry · 117d
Cleared May 25, 2011
TIGER SPINE SYSTEM
K110321 · MNH
Corelink, LLC
Orthopedic · 111d
Cleared May 25, 2011
NANOTACK SUTURE ANCHOR 1.4MM
K110473 · MBI
Pivot Medical
Orthopedic · 96d
Cleared May 25, 2011
LEUCADIA PEDICLE SCREW SYSTEM
K110588 · NKB
Phygen, LLC
Orthopedic · 84d
Cleared May 25, 2011
ABG II MONOLITHIC HIP STEM
K110807 · MAY
Stryker Corp.
Orthopedic · 63d
Cleared May 24, 2011
AZE VIRTUALPLACE-MR FLOW ANALYSIS SOFTWARE
K102534 · LLZ
Aze, Ltd.
Radiology · 263d
Cleared May 24, 2011
ARSTASIS DILATOR ADAPTER
K103421 · DRE
Arstasis, Inc.
Cardiovascular · 183d
Cleared May 24, 2011
4D LV-ANALYSIS 3.0
K110746 · DQK
Tomtec Imaging Systems GmbH
Radiology · 68d
Cleared May 24, 2011
TOTAL SHOULDER SYSTEM
K110905 · KWS
Shoulder Innovations, LLC
Orthopedic · 54d
Cleared May 24, 2011
SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM
K111153 · GDW
C.R. Bard, Inc.
General & Plastic Surgery · 29d
Cleared May 24, 2011
ANGIOJET SOLENT OMNI THROMBECTOMY SET
K111182 · QEZ
Medrad, Inc.
Cardiovascular · 27d
Cleared May 24, 2011
ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME...
K111183 · KWP
Orthofix, Inc.
Orthopedic · 27d
Cleared May 24, 2011
SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW
K111230 · HWC
Synthes USA Products, LLC
Orthopedic · 22d
Cleared May 24, 2011
EBW NM 2.0
K111336 · LLZ
Philips Medical Systems (Cleveland),...
Radiology · 12d
Cleared May 24, 2011
LIFEBRIDGE
K111384 · KFM
Lifebridge Medizintechnik AG
Cardiovascular · 7d
Cleared May 23, 2011
EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017
K101037 · LFR
Eps Bio Technology Corp.
Chemistry · 404d
Cleared May 23, 2011
OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)
K102199 · LXB
Sophono, Inc.
Ear, Nose, Throat · 292d
Cleared May 23, 2011
GORE EMBOLIC FILTER
K103500 · NTE
W.L. Gore & Associates, Inc.
Cardiovascular · 175d
Cleared May 23, 2011
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
K110155 · LZA
Tangshan Xiangrui Plastic Products...
General Hospital · 124d
Cleared May 23, 2011
SLIT LAMP SL-2G
K110489 · HJO
Topcon Medical Systems, Inc.
Ophthalmic · 90d
Cleared May 23, 2011
TSRH SPINAL SYSTEM
K110676 · NKB
Medtronic Sofamor Danek
Orthopedic · 74d