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
58585–58608 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 2007
HARPOON SUTURE ANCHOR
K071816 · HWC
Biomet Sports Medicine, Inc.
Orthopedic · 80d
Cleared Sep 20, 2007
ALWAYS MENSTRUAL PADS
K071827 · HHD
Procter & Gamble, Inc.
Obstetrics & Gynecology · 79d
Cleared Sep 20, 2007
STRYKER CROSSFIRE SYSTEM
K071859 · GEI
Stryker Endoscopy
General & Plastic Surgery · 77d
Cleared Sep 20, 2007
S4 SPINAL SYSTEM
K071945 · NKB
Aesculap Implant Systems
Orthopedic · 69d
Cleared Sep 20, 2007
DIODE MEDICAL LASER FAMILY, MODELS 4, 6, 30
K072034 · GEX
Quanta System Spa
General & Plastic Surgery · 57d
Cleared Sep 20, 2007
UCP MULTIPLE DRUG SCREEN TEST CUPS
K072062 · LFG
Ucp Biosciences, Inc.
Toxicology · 55d
Cleared Sep 20, 2007
BIOMET FEMORAL LOCKING NAIL SYSTEM
K072161 · HSB
Biomet Manufacturing Corp
Orthopedic · 45d
Cleared Sep 20, 2007
CONFORMIS METAL BACKED TIBIAL COMPONENT
K072368 · HSX
Conformis, Inc.
Orthopedic · 28d
Cleared Sep 20, 2007
VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1...
K072440 · CJY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 21d
Cleared Sep 20, 2007
REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM
K072489 · NBW
Taidoc Technology Corporation
Chemistry · 16d
Cleared Sep 20, 2007
EMBRACE GEL
K072515 · MUI
Orison Corporation
Radiology · 13d
Cleared Sep 19, 2007
NEURO WAVE 6
K062003 · GZJ
Lhasa Oms, Inc.
Neurology · 429d
Cleared Sep 19, 2007
PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112
K063735 · DRT
Presym, Inc.
Cardiovascular · 275d
Cleared Sep 19, 2007
PERIPHERAL GUIDING SHEATH
K070816 · DYB
Micrus Design Technology, Inc.
Cardiovascular · 177d
Cleared Sep 19, 2007
MODIFICATION TO SPINAL USA VBR SYSTEM
K070922 · KWQ
Spinal USA
Orthopedic · 170d
Cleared Sep 19, 2007
PULL TAB SQUEEZE FLUSH
K070979 · KRA
Icu Medical, Inc.
Cardiovascular · 166d
Cleared Sep 19, 2007
CROSSLINKED POLYETHYLENE ARTICULAR INSERTS
K071071 · JWH
Smith & Nephew, Inc.
Orthopedic · 156d
Cleared Sep 19, 2007
SPI EASY 4.0 ABUTMENT
K071453 · NHA
Thommen Medical AG
Dental · 117d
Cleared Sep 19, 2007
ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM
K071604 · JCT
Alveolus, Inc.
General & Plastic Surgery · 99d
Cleared Sep 19, 2007
PERMA FACIAL IMPLANTS
K071823 · ODU
Surgisil
General & Plastic Surgery · 78d
Cleared Sep 19, 2007
NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL
K071929 · HAW
Orthosoft, Inc.
Neurology · 68d
Cleared Sep 19, 2007
MINI LED AUTOFOCUS
K072181 · EBZ
Satelec
Dental · 44d
Cleared Sep 19, 2007
DORADO PTA BALLOON DILATATION CATHETER
K072283 · DQY
Bard Peripheral Vascular, Inc.
Cardiovascular · 34d
Cleared Sep 19, 2007
FIBRINOGEN CALIBRATOR KIT
K072304 · GFX
Dade Behring, Inc.
Hematology · 33d