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

Filters: Cleared only ×
176,076 results
63913–63936 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 2006
RIO ASPIRATION CATHETER
K051880 · QEZ
Boston Scientific Corp
Cardiovascular · 177d
Cleared Jan 04, 2006
ECHELON MICRO CATHETER
K051990 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 166d
Cleared Jan 04, 2006
FASTPACK TSH IMMUNOASSAY
K052301 · JLW
Qualigen, Inc.
Chemistry · 135d
Cleared Jan 04, 2006
HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL
K052697 · GGN
Akers Biosciences, Inc.
Hematology · 98d
Cleared Jan 04, 2006
SMARTPREP2 CENTRIFUGE SYSTEM
K052925 · JQC
Harvest Technologies, Corp.
Hematology · 78d
Cleared Jan 04, 2006
SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
K053135 · LKM
Sysmex America, Inc.
Pathology · 57d
Cleared Jan 04, 2006
BIPAP FOCUS
K053168 · MNS
Respironics (Ireland) Limited
Anesthesiology · 51d
Cleared Jan 04, 2006
KODAK CARESTREAM PACS
K053347 · LLZ
Eastman Kodak Company
Radiology · 33d
Cleared Jan 04, 2006
TREND 200 CPAP DEVICE, MODEL 5CP201
K053486 · BZD
Hoffrichter GmbH
Anesthesiology · 20d
Cleared Jan 03, 2006
GRAFTON DBM
K051188 · NUN
Osteotech, Inc.
Dental · 238d
Cleared Jan 03, 2006
EXPASYL POWER APPLICATOR
K051933 · ELW
Sybron Dental Specialties, Inc.
Dental · 174d
Cleared Jan 03, 2006
TESLAGUARD, MODEL EFT G04
K052119 · MWI
Mammendorfer Institute For Physics &...
Cardiovascular · 152d
Cleared Jan 03, 2006
STRAUMANN COMPUTER AIDED RESTORATION SERVICE
K052272 · NHA
Straumann USA
Dental · 134d
Cleared Jan 03, 2006
POWERHEART ECD
K052316 · MKJ
Cardiac Science, Inc.
Cardiovascular · 131d
Cleared Jan 03, 2006
FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH...
K053065 · LQZ
Bryan Keropian Dds
Dental · 63d
Cleared Jan 03, 2006
SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM
K053530 · IYN
Medison Co., Ltd.
Radiology · 15d
Cleared Dec 30, 2005
STRYKER INJECTABLE CEMENT
K051603 · MQV
Stryker Leibinger Micro Implants
Orthopedic · 198d
Cleared Dec 30, 2005
ENCORE CLP OFFSET TOTAL HIP SYSTEM
K052320 · KWA
Encore Medical Corporation
Orthopedic · 127d
Cleared Dec 30, 2005
PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30
K052795 · HGM
Philips Medizin Systeme Boeblingen GmbH
Obstetrics & Gynecology · 88d
Cleared Dec 30, 2005
FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)
K052862 · LQZ
Bryan Keropian Dds
Dental · 80d
Cleared Dec 30, 2005
CAAS
K052988 · LLZ
Pie Medical Imaging BV
Radiology · 67d
Cleared Dec 30, 2005
WIRELESS PHYSIOLOGIC MONITORING SYSTEM
K053016 · DXO
Edwards Lifesciences, LLC
Cardiovascular · 65d
Cleared Dec 30, 2005
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
K053020 · MMI
Bayer Healthcare, LLC
Chemistry · 65d
Cleared Dec 30, 2005
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
K053131 · JFM
Wako Chemicals USA, Inc.
Chemistry · 52d