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
79873–79896 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 2001
SYMMETRY AORTIC CLIP SYSTEM
K003446 · NCA
St. Jude Medical Cardiovascular...
General & Plastic Surgery · 196d
Cleared May 21, 2001
VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT
K003589 · HAW
Brainlab AG
Neurology · 182d
Cleared May 21, 2001
CARDIAC VIEW, MODEL 2001
K010513 · MOS
Magna-Lab, Inc.
Radiology · 89d
Cleared May 21, 2001
HARMONE-SCHWARZER EEG SYSTEM
K010728 · OLV
Stellate Systems
Neurology · 70d
Cleared May 21, 2001
LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES
K010834 · GEX
Laserscope
General & Plastic Surgery · 62d
Cleared May 21, 2001
ANALYST PANELS + ANALYTICAL TEST ROTOR
K010864 · KHS
Hemagen Diagnostics, Inc.
Chemistry · 60d
Cleared May 21, 2001
CDMX
K010915 · MUH
Camsight Co., Inc.
Radiology · 55d
Cleared May 21, 2001
MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K010936 · OXD
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 54d
Cleared May 21, 2001
SCREW-VENT DENTAL IMPLANT SYSTEM
K011028 · DZE
Sulzer Dental, Inc.
Dental · 46d
Cleared May 18, 2001
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
K002948 · DAP
Kamiya Biomedical Co.
Hematology · 239d
Cleared May 18, 2001
VASO PRESS DVT FOOT GARMENT #VP 520
K003828 · JOW
Britt Corp., Inc.
Cardiovascular · 158d
Cleared May 18, 2001
EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021,...
K010162 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 121d
Cleared May 18, 2001
VENA TECH VENA CAVA FILTER
K010485 · DTK
Bbraun
Cardiovascular · 87d
Cleared May 18, 2001
ADVANTA SST GRAFT (>_6MM)
K010516 · DSY
Atrium Medical Corp.
Cardiovascular · 85d
Cleared May 18, 2001
ADVANTA SST GRAFT (<6MM)
K010517 · DSY
Atrium Medical Corp.
Cardiovascular · 85d
Cleared May 18, 2001
CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
K010644 · FMQ
Skil-Care Corp.
General Hospital · 74d
Cleared May 18, 2001
MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE
K010672 · GAM
Gramsmed, LLC
General & Plastic Surgery · 73d
Cleared May 18, 2001
MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL...
K010689 · GEX
Biolitec, Inc.
General & Plastic Surgery · 71d
Cleared May 18, 2001
SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR
K010690 · DZL
Synthes (Usa)
Dental · 71d
Cleared May 18, 2001
SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES
K010710 · GEI
Seedling Enterprises., LLC
General & Plastic Surgery · 70d
Cleared May 18, 2001
FISTULOK FISTULA NEEDLE PROTECTION
K010958 · FMI
Diasol, Inc.
General Hospital · 49d
Cleared May 18, 2001
TINA-QUANT ALPHA-1 ANTITRYPSIN
K010978 · DEM
Rochdiag
Immunology · 66d
Cleared May 18, 2001
HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3
K011169 · JJY
International Enzymes, Inc.
Chemistry · 31d
Cleared May 18, 2001
GE LOGIQ 9, MODEL 2188900-X
K011188 · IYN
GE Medical Systems
Radiology · 30d