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
46225–46248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 2011
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7...
K112086 · DXT
Medrad, Inc.
Cardiovascular · 85d
Cleared Oct 14, 2011
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
K112370 · MRZ
Welldoc, Inc.
General Hospital · 58d
Cleared Oct 14, 2011
EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER
K112694 · DXC
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Oct 14, 2011
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
K112771 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 21d
Cleared Oct 14, 2011
NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT
K112773 · MQV
Novabone Products, LLC
Orthopedic · 21d
Cleared Oct 13, 2011
NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
K100163 · FPD
Vygon Corp.
Gastroenterology & Urology · 631d
Cleared Oct 13, 2011
MONARCH III IOL DELIVERY SYSTEM
K101774 · MSS
Alcon Manufacturing, Ltd.
Ophthalmic · 476d
Cleared Oct 13, 2011
3B FLEX-LITE
K103434 · BZD
3B Products, LLC
Anesthesiology · 324d
Cleared Oct 13, 2011
IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT
K103757 · CFF
Grifols
Immunology · 294d
Cleared Oct 13, 2011
MTF NEW BONE VOID FILLER
K110003 · MQV
Musculoskeletal Transplant Foundation
Orthopedic · 283d
Cleared Oct 13, 2011
INVISIPORT
K110407 · LJT
Stealth Therapeutics, Incorporated
General Hospital · 241d
Cleared Oct 13, 2011
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT...
K111492 · JWH
Materialise NV
Orthopedic · 135d
Cleared Oct 13, 2011
DISPOSABLE STIMULATING ELECTRODE
K111597 · ETN
Nuvasive, Inc.
Ear, Nose, Throat · 127d
Cleared Oct 13, 2011
SULCUS BLUE
K111978 · MVL
Produits Dentaires Pierre Rolland
Dental · 93d
Cleared Oct 12, 2011
PRODIGY DIABETES MANAGEMENT SOFTWARE
K103115 · NBW
Prodigy Diabetes Care, LLC
Chemistry · 356d
Cleared Oct 12, 2011
SFC VERTEBRAL BODY REPLACEMENT
K110153 · MQP
Konigsee Implantate GmbH
Orthopedic · 266d
Cleared Oct 12, 2011
BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER
K110646 · MUA
Beam-Med, Ltd.
Radiology · 222d
Cleared Oct 12, 2011
FEMCHEC PRESSURE MANAGEMET DEVICE
K110993 · LKF
Femasys, Inc.
Obstetrics & Gynecology · 187d
Cleared Oct 12, 2011
MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM
K111200 · DQK
Ge Healthcare
Cardiovascular · 166d
Cleared Oct 12, 2011
CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM
K111264 · ODP
Medtronic Sofamor Danek USA
Orthopedic · 161d
Cleared Oct 12, 2011
VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)
K111543 · NOT
Ventana Medical Systems, Inc.
Pathology · 132d
Cleared Oct 12, 2011
BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP
K112019 · KWY
Corentec Co., Ltd.
Orthopedic · 90d
Cleared Oct 12, 2011
LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE
K112051 · LLZ
Broncus Technologies, Inc.
Radiology · 86d
Cleared Oct 12, 2011
BANTAM CATHETER (280MM BALLOON LENGTHS)
K112335 · DQY
ClearStream Technologies , Ltd.
Cardiovascular · 61d